Wood Stove Interventions and Child Respiratory Infections in Rural Communities
Phase: NA
Conditions: Lower Tract Respiratory Infection
Sponsor: University of Montana

PROTOCOL TITLE: Wood stove interventions and child respiratory infections in rural communities 
ClinicalTrials.gov Number: NCT02240134
PRINCIPAL INVESTIGATOR(S): Curtis W. Noonan and Tony J. Ward, School of Public and Community 
Health Sciences, University of Montana, 406-243-4957, curtis.noonan@umontana.edu 
RESEARCH LOCATION(S): University of Montana, Missoula, MT; University of New Mexico, 
Albuquerque, NM; University of Alaska, Fairbanks, AK 
DOCUMENT DATE: November 11, 2015 
PROTOCOL AND REVISION HISTORY: 
Version 
Approval 
Date, 
mm/dd/yyyy 
Summary of Change 
12/23/2013 
Original protocol 
08/26/2014 
Amendment for approval of recruitment flyers and media 
09/22/2014 
The following changes were made in the parental permission form 
1. We will collect data about your home and child during two, six-month
winter periods. For the data about your home, we will conduct up to two
visits in the first winter.
2. At each of these visits we will place devices in your home for up to 6 days
to measure temperature and dust.
10/27/2014 
Data collection protocols and forms 
12/23/2014 
Addition of wipe sample collection to assess nicotine in homes. 
Parental permission form revised to include: “Once per winter, we will collect 
a nicotine wipe sample from a surface in the home that is very rarely cleaned 
(e.g., top of a door jam).” 
05/21/2015 
Amendment for approval of recruitment materials 
06/22/2015 
Amendment for approval of social media and radio recruitment messages 
09/14/2015 
Amendment to add two question added to Child Symptom Questionnaire:  
Did anyone in the home miss work because of your child’s illness? No  Yes 
If yes, for how many days: 
10/02/2015 
Amendment to add two questions to Home Characteristics Questionnaire: 
Does anyone in the household smoke? 
No 
Yes 
If yes, do they smoke inside the home? 
No 
Yes 
11/11/2015 
Amendment to add End of Winter Home Questionnaires and Knowledge, 
Attitudes, Behaviors (KAB) survey 
ATTACHMENTS: 
Original protocol: ‘LRTIR01protocol.12_23_2013’ 
Data collection protocols and forms: ‘Child Health Measures Visit Protocol 10272014’ 
End of Winter Home Questionnaires and KAB survey: ‘End of Winter Questionnaires and KAB 11112015’ 
Statistical Analysis Plan 

 
1
THE UNIVERSITY OF MONTANA-MISSOULA 
Institutional Review Board (IRB) 
for the Protection of Human Subjects in Research 
CHECKLIST / APPLICATION 
At the University of Montana (UM), the Institutional Review Board (IRB) is the institutional review body responsible for oversight of all 
research activities involving human subjects outlined in the U.S. Department of Health and Human Services’ Office of Human Research 
Protection and the National Institutes of Health, Inclusion of Children Policy Implementation. 
Instructions:  A separate application form must be submitted for each project.  IRB proposals are approved for no longer than one year 
and must be continued annually (unless Exempt).  Faculty and students may email the completed form as a Word document to 
IRB@umontana.edu. or submit a hardcopy to the Office of the Vice President for Research & Creative Scholarship, University Hall 116.  
Student applications must be accompanied by email authorization by the supervising faculty member or a signed hard copy.  All fields 
must be completed.  If an item does not apply to this project, write in: n/a.  Questions?  Call 243-6672. 
1.
Administrative Information
Project Title:  Wood stove interventions and child respiratory infections in rural communities 
Principal Investigator: Curtis Noonan and Tony Ward 
UM Position: Assoc Professor 
Department: CEHS/BMED 
Office location: Skaggs 
Work Phone: 406-243-4957 
Cell Phone:  
2.
Human Subjects Protection Training (All researchers, including faculty supervisors for student projects, must have completed a self-
study course on protection of human research subjects within the last three years (http://www.umt.edu/research/complianceinfo/IRB/) and be able
to supply the “Certificate(s) of Completion” upon request.  If you need to add rows for more people, contact the IRB office for assistance.
All Research Team Members (list yourself first) 
PI 
CO-PI 
Faculty 
Supervisor 
Research 
Assistant 
DATE COMPLETED 
Human Subjects 
Protection Course 
Name: Curtis Noonan 
Email: curtis.noonan@umontana.edu 
9/20/2011 
Name: Tony Ward 
Email: tony.ward@umontana.edu 
12/28/2012 
Name: Erin Semmens 
Email: erin.semmens@umontana.edu 
3/26/2013 
Name: Desirae Ware 
Email: desirae.ware@umontana.edu 
11/4/2013 
3.
Project Funding   (If federally funded, you must submit a copy of the abstract or Statement of Work.)
Is grant application currently under review at a grant funding 
agency?   
Yes (If yes, cite sponsor on ICF if applicable)  
No 
Has grant proposal received approval and funding? 
Yes (If yes, cite sponsor on ICF if applicable)  
No 
Agency 
Grant No. 
Start Date 
End Date 
PI on grant 
NIEHS 
Ward and Noonan 
For UM-IRB Use Only 
IRB Determination: 
_____ Not Human Subjects Research 
_____ Approved by Exempt Review, Category # ______ (see memo) 
_____ Approved by Expedited Review, Category #______ (see Note to PI) 
_____ Full IRB Determination 
     _____ Approved (see Note to PI) 
 _____ Conditional Approval (see memo) - IRB Chair Signature/Date: _________________________________ 
 _____ Conditions Met (see Note to PI) 
 _____ Resubmit Proposal (see memo) 
   Risk Level: _________________________ 
 _____ Disapproved (see memo) 
Final Approval by IRB Chair/Manager: __________________________ Date: _______________ Expires: ______________ 
IRB Protocol No.: 
_______________ 
Form RA-108 
 (Rev. 11/13) 
Note to PI:  Non-exempt studies are approved for one year 
only.  Use any attached IRB-approved forms (signed/dated) 
as “masters” when preparing copies.  If continuing beyond 
the expiration date, a continuation report must be submitted. 
Notify the IRB if any significant changes or unanticipated 
events occur.  When the study is completed, a closure report 
must be submitted. Failure to follow these directions 
constitutes non-compliance with UM policy.

2
<In an effort to be environmentally responsible, please expand/reduce box size as needed.> 
4. Purpose of the Research Project:  Briefly summarize the overall intent of the study.  Your target audience is a non-researcher.
Include in your description a statement of the objectives and the potential benefit to the study subjects and/or the advancement of your
field.  Generally included are literature related to the problem, hypotheses, and discussion of the problem’s importance. Expand
box as needed.
Acute lower respiratory tract infections (LRTIs) account for more than 27% of all hospitalizations among US 
children under five years of age, with recurrent LRTIs in children a recognized risk factor for asthma. Within 
rural areas of Montana, Alaska, and the Navajo Reservation, research has shown that residential biomass 
combustion leads to elevated indoor levels of fine particulate matter (PM2.5) that often exceed current healthbased 
air quality standards. Parallel findings have been observed in several developing countries where 
biomass combustion is commonly used for cooking and/or heating. This is concerning, as PM2.5 exposure is 
associated with many adverse health outcomes, including a greater than three-fold increased risk of LRTIs. 
Currently, there is a global effort to reduce indoor biomass smoke exposures in developing countries through 
the introduction of improved cookstove technology. Similar evidence-based efforts are warranted in rural and 
Native American communities in the US that suffer from elevated rates of childhood LRTI and commonly use 
wood for residential heating. To date, exposure reduction strategies in wood stove homes have been either 
inconsistently effective or include factors that limit widespread dissemination and continued compliance in rural 
and economically disadvantaged populations. In this project, we propose to test the efficacy of two intervention 
strategies for reducing indoor wood smoke PM2.5 exposures and children’s risk of LRTI in three unique and 
underserved settings: (1) rural mountain valley communities in western Montana; (2) Navajo Nation 
communities; and (3) Alaska Native Villages. We will conduct a three-arm randomized placebo-controlled postonly 
intervention trial in wood stove homes with children less than five years old. Education on best-burn 
practices and training on the use of simple instruments (i.e., stove thermometers and wood moisture meters) 
will be introduced as one intervention arm (Tx1). This intervention will be evaluated against an indoor air 
filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters). The primary outcome will be LRTI 
incidence among children under five years of age. To allow for detection of exposure and outcome differences 
within each of the three regions, a sample of 324 homes, or 108 within each study area will be equally 
assigned to each of the three intervention arms. The overall hypothesis is that a low-cost, educational 
intervention targeting indoor wood smoke PM2.5 exposures will be sustainable, and can reduce children’s risk 
of LRTI in underserved Native and rural communities. 
This checklist submitted to the University of Montana IRB is specific for the activities in study area 1: rural mountain 
valley communities in western Montana. As indicated below (item #5) the other two study sites will fall under the 
jurisdication of the respective local IRBs.  
        4.1   What do you plan to do with the results? If not discussed above, include considerations such as whether this is a class project, a 
project to improve a program/school system, and/or if the results will be generalized to a larger population, contribute to the general field 
of knowledge, and/or be published/presented in any capacity. 
Results will be generalized to other communities and households that burn biomass for residential heating. Results of 
this research will be published in peer reviewer journals. 
Is this part of a thesis or dissertation?       
No        
Yes  If yes and other than the PI’s, then whose?  
5. IRB Oversight
Is oversight required by other IRB(s) [e.g., tribal, hospital, other university] for this project? 
Yes     
 No     
If yes, please identify IRB(s):  
This study will be approved by The University of Montana Institutional Review Board (UM-IRB). Approval for study 
site 2 will be submitted to the Navajo Nation Human Research Review Board. Approval for study site 3 will be 
submitted to the Alaska Area Institutional Review Board (AAIRB), and the Yukon Kuskokwim Health Corporation 
Human Studies Committee.  
6. Subject Information:
  6.1   Human Subjects (identify, include age/gender): 
Eligible subjects will include children less than 5 years of age that live in a household that utilizes a wood stove as the 
primary heating source in the study region (i.e., rural Montana). We anticipate an equal number of male and female 
child participants. A total of 108 households from this study area will be recruited for this study. We assume 
approximately 1.5 children under 5 years old per household (n = 162 total child subject). 

3
6.2   How many subjects will be included in the study?   162 
6.3   Are minors included (under age 18, per Montana law)? 
 Yes     
 No    
 If yes, specify age range: 0 to 5 
6.4   Are members of a physically, psychologically, or socially vulnerable population being specifically targeted? 
Yes        
 No     
If yes, please explain why the subjects might be physically, psychologically or socially vulnerable: 
6.5   Are there other special considerations regarding this population? 
Yes   
 No   
If yes, please explain:  
6.6   Do subjects reside in a foreign country?    
 Yes  Specify country:   
 No     
If yes, please fill out and attach Form RA-112, Foreign Site Study Appendix 
(http://www.umt.edu/research/complianceinfo/IRB/Docs/foreign.doc). 
6.7   How are subjects selected or recruited?  Include a bulleted list of inclusion/exclusion criteria.  (Attach copies of all 
flyers, advertisements, etc,. that will be used in the  recruitment process as these require UM-IRB approval)  
For the western Montana study area, we will recruit participants through the local medical center, pediatricians’ 
offices, and the Women, Infants and Children (WIC) programs. In addition, we will communicate directly with 
obstetricians, pediatricians, and WIC community nurses to describe the study, and provide recruitment materials such 
as flyers and post cards to be returned by potentially eligible participants.   
Inclusion criteria: 
- Eligible homes will be any home that uses a wood stove as a primary heating source, and has one or more children
under the age of five years. The home must include a parent who is capable and willing to record symptom data for
the enrolled children and wood stove usage data.
Exclusion criteria: 
- None.
6.8   How will subjects be identified in your personal notes, work papers, or publications: (may check more than one) 
  Identified by name and/or address or other 
(Secure written [e.g., ICF] or verbal permission to identify; if risk exists, create a confidentiality plan.) 
  Confidentiality Plan 
(Identity of subjects linked to research, but not specific data [e.g., individuals identified in ICF but not included in 
publications]; identification key kept separate from data; or, data collected by third party [e.g., Select Survey, 
SurveyMonkey, etc.] and identifiers not received with data.) 
  Never know participant’s identity 
(An ICF may be unnecessary [e.g, anonymous survey, paper or online] unless project is sensitive or involves a 
vulnerable population.) 
 6.9   Describe the means by which the human subject’s personal privacy is to be protected, and the confidentiality of     
information maintained.  If you are using a Confidentiality Plan (as checked above), include in your description a plan for 
the destruction of materials that could allow identification of individual subjects or the justification for preserving 
identifiers.    
All households, and child subjects within household, will be assigned unique identification numbers. For practical 
purposes, the PI or appropriate study personnel will have a linkage file on-site (e.g., a file that identifies the subjects 
and their corresponding numbers) during the data collection days to ensure that the correct subjects are identified. At 
all other times, this linkage file will be under the control of the University of Montana PIs. The linkage file will be 
kept separate from other data materials. When sample collection is completed, this linkage file will be returned to a 
locked file cabinet under the control of Co-PI Noonan. Data will be recorded on data collection sheets that contain 
only the subject’s identification number and no other personal identifiers. 

 
 
 
 
4
 
6.9a   Will subject(s) receive an explanation of the research – separate from the informed consent form (if applicable) – 
before and/or after the project?     
 Yes (attach copy and explain when given)   
 No      
 
7.   Information to be Compiled 
 
7.1   Explain where the study will take place (physical location not geographic). If permission is required to conduct the 
 
research at the location or to use any of the facilities, indicate those arrangements and attach copies of written permission:  
The study will take place in the children's homes. 
 
 
7.2   Will you be working with infectious materials, ionizing radiation, or hazardous materials?  Please specify.  
N/A 
 
 
7.3   Subject matter or kind(s) of information to be compiled from/about subjects:  
The primary health outcome will be occurrence of LRTI among children, and will be assessed using active 
surveillance within the home. Identification of LRTI episodes will occur through a three step process: (1) parent 
reporting of symptoms; (2) Community Coordinator collection of confirmatory and severity data; and (3) physician 
classification of case status based on data collected by the Community Coordinator, and when available, data collected 
from a clinic or hospital. 
 
At the onset of the program in each study area, comprehensive health outcomes assessment training of Community 
Coordinators will be provided by Drs. Paul Smith and Curtis Noonan. Community Coordinators will then train parents 
in the identification of symptoms consistent with LRTI (cough, difficulty breathing, fast breathing, noisy breathing, 
nasal discharge, loss of appetite and fever). Parents will be asked to contact their Community Coordinator when such 
symptoms are present in household children <five years (Step 1). Home visits will occur within 48 hours of parent 
notification of signs and symptoms of LRTI. At this visit, the Community Coordinator will interview the parent about 
each study participant’s symptoms. The Community Coordinator will then measure temperature, respiratory rate and 
saturated oxygen, and evaluate the child for presence of chest indrawing (retractions), wheeze and cough (Step 2). 
Please note that the Community Coordinators are not diagnosing respiratory illness or providing medical care, and 
parents will be encouraged to seek medical care for treatment of their child’s respiratory symptoms, when indicated 
(see also Protection of Human Subjects section). For any study participant experiencing symptoms, the Community 
Coordinator will document the presence of symptoms and date of onset with the parent. During the regular 
communication with the parent and subsequent home visits, the Community Coordinator will continue to track this 
child’s symptoms. The last day of cough and rapid breathing with no recurrence of symptoms during a following 14 
day period will be considered the end date for a given episode. Per approaches used internationally, if symptoms recur 
within a period of less than 14 days, these symptom days will be considered part of the immediately preceding episode 
rather than a separate episode. Days with cough as the only symptom will not be included as days for the given LRTI 
episode. The Community Coordinator will also determine if the child was observed by a health care provider, clinic or 
hospital during this episode. If available, health data from such visits will be collected from the covered entity with the 
corresponding parent-signed HIPPA forms. Data collected from medical records will include health care provider 
diagnosis, ausculatory findings, and laboratory/radiological findings. 
 
The Step 1 strategy may be adversely impacted by lack of follow-up by the parent or communication barriers that may 
vary by community. To address this, the Community Coordinator will engage in active and frequent surveillance of 
homes (Step 2), interviewing the parent at a minimum of once every two weeks regarding symptoms among study 
participants. This communication will occur via telephone, email, or a home visit depending upon the community 
setting and the preferred method of communication. The Community Coordinator will also visit the home at a 
minimum of once per month to measure respiratory rate and saturated oxygen, regardless of whether or not the parent 
has reported child symptoms consistent with LRTI. When indicated the Community Coordinator will collect objective 
measures and prospectively track symptoms according to the Step 1 procedures indicated above. 
 
For primary analysis, the final case determination will be made by pediatric pulmonologist, Paul Smith, D.O (Step 3). 
The primary case definition will be based on the objective data collected by the Community Coordinator. Children <5 
years will be considered to have LRTI if the Community Coordinator documents cough and a respiratory rate ≥40 
breaths per minute in children <1 year or ≥30 breaths per minute in children 1 to <5 years. The primary determinants 
of LRTI status (i.e., respiratory rate and presence of cough) are easily captured by trained Community Coordinators. 
The respiratory rate thresholds are highly sensitive indicators for presence of LRTI. To improve specificity for LRTI, 
Dr. Smith will further distinguish between moderate and severe LRTI (i.e., secondary case status determination) 

 
 
 
 
5
according to the presence of fever, chest indrawing, wheeze and saturated oxygen readings <90% as documented from 
direct field observation or from clinical records. 
 
Other data collection: We will capture additional data that may be relevant to either risk of LRTI or PM2.5 exposures. 
Individual-level characteristics to be captured from parents will include child’s vaccination history, occurrence and 
duration of breastfeeding, birth weight, and maternal age. Household-level characteristics will include crowding, 
presence of mold, cleanliness, parent education level, household income, and household tobacco smokers. To 
supplement the reporting of household tobacco use, we will collect household surface dust wipe samples at each 
exposure sampling visit to measure deposited nicotine. Alcohol wipes will be collected from horizontal surface areas 
within the home in areas that are not frequently cleaned (top of doors, top of cabinets, etc.). Following a revised 
method utilized by the US Centers for Disease Control and Prevention,101 analysis for nicotine will be performed 
from the wipes using Gas Chromatography/Mass Spectrometry (GC/MS) at UM under the direction of Dr. Tony 
Ward. Exposures could also be impacted at the household level by various factors such as the use of power generators 
or the use of materials other than wood in stoves, with some activities specific to the study sites. 
 
 
7.4   Activities the subjects will perform and how the subjects will be used. Describe the instrumentation and procedures to 
 
be used and kinds of data or information to be gathered.  Provide enough detail so the IRB will be able to evaluate the 
 
intrusion from the subject’s perspective (expand box as needed):  
During assessment of suspected LRTI, the Community Coordinator will measure the child's temperature, respiratory 
rate and saturated oxygen, and evaluate the child for presence of chest indrawing (retractions), wheeze and cough. 
This will take approximately 15 minutes for each time these factors are assessed for a given child. These same 
measures will be captured for the child each time the Community Coordinator visits the child's home. These visits will 
occur once per month for two six-month winter periods, or a total of 12 visits. 
 
7.5   Is information on any of the following included? (check all that apply): 
 
  Sexual behavior 
 
 
 
  Drug use/abuse 
 
  Alcohol use/abuse 
 
 
 
  Illegal conduct 
 
  Information about the subject that, if it became known outside the research, could reasonably place the  
      
       subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or  
      
       employability. 
 
 
7.6   Means of obtaining the information (check all that apply). Attach questionnaire or survey instrument, if used: 
  Field/Laboratory observation 
  In-person interviews/survey   
  Blood/Tissue/Urine/Feces/Semen/Saliva  
  Telephone interviews/survey  
       Sampling (IBC Application must be submitted)  
  On-site survey  
 
  Medical records (require HIPAA form)  
  Mail survey  
 
  Measurement of motions/actions 
     
  Online survey (attach Statement of Confidentiality) 
 
  Use of standard educational tests, etc.         
  Examine public documents, records, data, etc. 
 
  Other means (specify):        
 
  Examine private documents, records, data, etc. 
 
 
 
7.7   Will subjects be (check all that apply):  
 
 
  Videotaped  
  Audio-taped  
  Photographed 
 
  N/A  
 
 
  
(securing an additional signature is recommended on consent/assent/permission forms) 
 
 
Explain how above media will be used, who will transcribe, and how/when destroyed: 
      
 
7.8   Discuss the benefits (does not include payment for participation) of the research, if any, to the human subjects and to 
scientific knowledge (if the subjects will not benefit from their participation, so state): 
Those who participate in this research may help inform health researchers, physicians, and the regulatory community 
about exposure to smoke from wood stoves and the impact of these exposures on susceptible populations. These 
findings will help identify interventions that will be generalizable to other rural impacted by wood smoke. Information 
collected from exposure assessments will also be made available to subjects at the end of their participation in the 
study. These data could be useful for identifying strategies to mitigate in home exposures to PM and respiratory 
morbidity among children. The study may benefit study participants directly through the collection of objective 
measures of their respiratory health. Although the Community Coordinators will not be diagnosing children or 
providing them with medical care, they will have information on normal ranges for respiratory rate, oxygen saturation, 
temperature and retractions and thus can refer children for medical care or make a recommendation for referral. In 
these cases, the participants may benefit from receiving care that they might not otherwise have sought.  

 
 
 
 
6
 
7.9   Cite any payment for participation (payment is not considered a benefit).  If grant funding is not indicated in item #2, 
please specify the source of the funding and in what form it is to be dispersed. 
Households, rather than the child subjects, will be payed for their participation. Each household participating in the 
project in western Montana will receive $100 per each of two winter periods, or a total of $200. 
 
7.9a   Outline, in detail, the risks and discomforts, if any, to which the human subjects will be exposed (Such deleterious 
effects may be physical, psychological, professional, financial, legal, spiritual, or cultural.  As a result, one can never 
guarantee that there are no risks – use “minimal.”  Some research involves violations of normal expectations, rather than 
risks or discomforts; such violations, if any, should be specified):  
This study will be conducted in the home of children less than 5 years of age. The household intervention does not 
involve any medications or changes to the child’s normal care. The proposed methods for assessing the presence of 
LRTI are non-invasive, including respiratory rate measures and recording of symptoms.  
 
 7.9b   Describe, in detail, the means taken to minimize each such deleterious effect or violation:: 
The Coordinators will be trained by our medical consultant to recognize when a child’s symptoms indicate the need 
for medical referral.  
 
8.   Informed Consent 
An informed consent form (ICF) is usually required, unless subjects remain anonymous or a waiver is otherwise justified 
below.  (Templates and examples of Informed Consent, Parental Permission, and Child’s Assent Forms are available at 
http://www.umt.edu/research/complianceinfo/irb/forms.aspx).   
 
A signed copy of the consent/assent/permission form must be offered to all subjects, including parents/guardians of 
subjects less than 18 years of age (minors). 
 
Use of minors 
o 
All minor subjects (under the age of 18) must have written parental or custodial permission (45 CFR 
46.116(b)). 
o 
All minors from 10 to 18 years of age are required to give written assent (45 CFR 46.408(a)).   
o 
Assent by minor subjects:  All minor subjects are to be given a clear and complete picture of the research 
they are being asked to engage in, together with its attendant risks and benefits, as their developmental 
status and competence will allow them to understand. 
o 
Minors less than 10 years of age and all individuals, regardless of age, with delayed cognitive 
functioning (or with communication skills that make expressive responses unreliable) will be denied 
involvement in any research that does not provide a benefit/risk advantage.   
 
Good faith efforts must be made to assess the actual level of competence of minor subjects 
where there is doubt.   
 
The Minor Assent Form must be written at a level that can be understood by the minor, and/or 
read to them at an age-appropriate level in order to secure verbal assent.  
 
Is a written informed consent form being used?  
 Yes (attach copy)    
 No (justify below) 
       To waive the requirement for written informed consent (45 CFR 46.117), describe your justification:  
      
 
Is a written parental permission form being used? 
 Yes (attach copy)    
 No 
(If yes, will likely require minor assent form) 
 
Is a written minor assent form being used?  
    
 Yes (attach copy)    
 No 
 
 
 
 
(If yes, will likely require parental permission form) 
 
 
 
Principal Investigator’s Statement 
By signing below, the Principal Investigator agrees to comply with all requirements of The University of Montana-Missoula IRB, 
the U.S. Department of Health and Human Services Office of Human Research Protection Guidelines, and NIH Guidelines.  The 
PI agrees to ensure all members of his/her team are familiar with the requirements and risks of this project, and will complete the 
Human Subject Protection Course available at http://www.umt.edu/research/complianceinfo/irb.  
 
I certify that the statements made in this application are accurate and complete. I also agree to the following: 
 
I will not begin work on the procedures described in this protocol, including any subject recruitment or data collection, 
until I receive final notice of approval from the IRB. 

 
 
 
 
7
 
I agree to inform the IRB in writing of any adverse or unanticipated problems using the appropriate form.  I further agree 
not to proceed with the project until the problems have been resolved. 
 
I will not make any changes to the protocol written herein without first submitting a written Amendment Request to the 
IRB using form RA-110, and I will not undertake such changes until the IRB has reviewed and approved them. 
 
It is my responsibility to ensure that every person working with the human subjects is appropriately trained. 
 
All consent forms and recruitment flyers must be approved and date-stamped by the IRB before they can be used.  The 
forms will be provided back to the PI in PDF format with the IRB approval email.  Copies must be made from the date-
stamped version.  All consent forms given to subjects must display the IRB approval date-stamp. 
 
I understand that it is my responsibility to file a Continuation Report before the project expiration date (does not apply 
to exempt projects).  This is not the responsibility of the IRB office.  Tip: Set a reminder on your calendar as soon as 
you receive the date.  A project that has expired is no longer in compliance with UM or federal policy. 
 
I understand that I must file a Closure Report (RA-109) when the project is completed, abandoned, or otherwise 
qualifies for closure from continuing IRB review (does not apply to exempt projects). 
 
I will keep a copy of this protocol (including all consent forms, questionnaires, and recruitment flyers) and all 
subsequent correspondence with the IRB. 
 
I understand that failure to comply with UM and federal policy, including failure to promptly respond to IRB requests, 
constitutes non-compliance and may have serious consequences impacting my project and my standing at The 
University of Montana. 
 
 
 
Signature of Principal Investigator:        
 
 
Date:       
 
      (Type for electronic submission; sign for hard copy) 
 
NOTE:  I AM AWARE that electronic submission of this form from my University email account constitutes my signature. 
 
 
 
 
 
 
Students and Faculty Advisors:  Student applications must be accompanied by either an email authorization from the 
supervising faculty member or by a signed hard copy (below). 
 
Faculty Supervisor:                                                                                                    
 
 
My signature confirms: 
1) I have read the IRB Application and attachments.   
2) I agree that it accurately represents the planned research.   
3) I will supervise this research project.  
 
Faculty Advisor Signature:       
 
 
 
Date:       
 
 
      (Type for electronic submission; sign for hard copy) 
 
Department:                                                                                   Phone:         

	  Child	  Health	  Measures	  Contacts	  and	  Visits	  	  
Initial	  visit	  (at	  time	  of	  recruitment/informed	  consent):	  
1. Review	  parental	  permission	  form	  and	  answer	  parent	  questions.	  	  	  
2. Review	  and	  complete	  HIPAA	  form.	  	  	  
3. Obtain	  assent	  from	  children	  age	  4	  and	  5	  years	  of	  age	  
4. Upon	  the	  receipt	  of	  signed	  parental	  permission	  (for	  all	  children)	  and	  child	  assent	  (for	  children	  
ages	  4-­‐5	  years),	  study	  personnel	  will	  ask	  the	  contact	  parent	  to	  complete	  the	  following	  
documents:	  
A.	  Demographics	  Form	  
B.	  Home	  Characteristics	  Form	  
C.	  Child	  Birth	  and	  Infancy	  Data	  
D.	  Authorization	  to	  Use	  and	  Disclose	  Protected	  Health	  Information	  for	  Research	  Purposes	  
	  
	  
Phone	  contacts	  and	  procedures	  for	  parent-­‐reporting	  of	  child	  symptoms:	  	  
• 
Provide	  study	  phone	  numbers.	  
• 
Provide	  instruction	  sheet	  for	  identifying	  child	  symptoms	  (see	  PARENT/CAREGIVER	  
REPORTING	  OF	  SYMPTOMS).	  
• 
When	  parent	  contacts	  study	  personnel,	  Child	  Symptom	  Questionnaire	  (below)	  will	  be	  
completed.	  
Study	  personnel	  also	  will	  monitor	  child	  symptoms	  via	  phone	  call	  with	  contact	  parent	  at	  a	  frequency	  
of	  once	  per	  two	  weeks	  during	  the	  winter	  period.	  Home	  visits	  will	  supersede	  phone-­‐based	  data	  
collection.	  	  
In	  phone	  communications,	  the	  Child	  Symptom	  Questionnaire	  will	  be	  completed.	  	  
	  
	  
	  

Home	  visits	  and	  data	  collections:	  
Home	  visits	  will	  occur	  at	  a	  frequency	  of	  once	  per	  month	  during	  the	  winter	  period,	  or	  as	  indicated	  by	  
phone	  contact	  that	  was	  initiated	  either	  by	  study	  personnel	  or	  contact	  parent.	  
Note:	  Even	  if	  the	  visit	  is	  initiated	  by	  illness	  report	  for	  a	  given	  child,	  when	  another	  study	  child	  resides	  in	  
the	  same	  home,	  these	  data	  also	  will	  be	  collected	  for	  that	  symptom-­‐free	  child.	  	  
At	  home	  visit,	  the	  following	  will	  be	  collected	  for	  each	  child	  participant:	  
• 
Child	  Symptom	  Questionnaire	  (parent	  response)	  
Note:	  Even	  if	  these	  symptom	  data	  were	  collected	  during	  a	  phone	  contact,	  these	  symptom	  data	  
should	  be	  collected	  again	  at	  home	  visit.	  
	  
• 
Health	  Measures	  Visit	  Sheet.	  Protocols	  for	  the	  following	  are	  included:	  
o Respiratory	  rate	  	  
o Heart	  rate	  and	  saturated	  oxygen	  	  (i.e.,	  pulse	  oximetry)	  
o Temperature	  	  
See	  also	  Referral	  Protocol.	  	  
	  
Capture	  of	  data	  from	  child’s	  health	  provider	  visit,	  when	  applicable:	  
If	  the	  parent	  has	  indicated	  that	  the	  child	  has	  been	  taken	  to	  a	  health	  care	  provider	  (see	  Child	  Symptom	  
Questionnaire),	  study	  personnel	  will	  request	  data	  from	  the	  respective	  health	  care	  provider.	  Per	  the	  
parent-­‐signed	  “Authorization	  to	  Use	  and	  Disclose	  Protected	  Health	  Information	  for	  Research	  Purposes,”	  
the	  following	  data	  will	  be	  requested:	  
• 
Diagnosis	  of	  respiratory	  tract	  infection,	  including	  both	  upper	  and	  lower	  respiratory	  infection;	  
• 
Lab	  results	  related	  to	  respiratory	  tract	  infection	  	  
Any	  results	  from	  respiratory	  “swabs”	  if	  obtained	  (RSV,	  influenza,	  pertussis,	  parainfluenza)	  
• 
presence	  of	  fever;	  
• 
observation	  of	  chest	  retractions;	  
• 
wheeze	  or	  other	  impaired	  breathing	  symptoms;	  and	  
• 
saturated	  oxygen	  readings	  
• 
chest	  radiographic	  information	  (positive	  or	  negative	  findings)	  
	  
	  
	  

Exposure	  sampling	  visits:	  
During	  the	  first	  winter,	  up	  to	  two	  sampling	  visits	  will	  occur	  to	  collect	  indoor	  air	  quality	  data.	  The	  air	  
sampling	  equipment	  will	  be	  placed	  by	  study	  personnel	  and	  will	  measure	  temperature	  and	  dust	  for	  up	  to	  
6	  days.	  The	  home	  participants	  will	  not	  need	  to	  assist	  with	  the	  air	  sampling	  equipment,	  but	  we	  will	  ask	  
them	  to	  complete	  the	  following	  forms:	  
• 
Home	  characteristics	  
• 
Home	  activity	  Log	  
• 
Wood	  stove	  usage	  
• 
In-­‐home	  Log	  
	  
	  

Page 1 of 2 
Demographic Questions for Primary Caregiver  
 
 
Home ID:_____________  
 
 
 
 
 
 
 
 
 
 
 
 Date: _______________ 
 
1.  Please circle one:  
Female 
 
Male 
 
 
2. Are you Hispanic or Latino? 
 
 
 
Yes 
 
No 
 
 
3.  What is your race? Circle one or more races to indicate what you consider yourself to be: 
 
 
American Indian/Alaskan Native 
 
 
Asian 
 
 
Native Hawaiian or Other Pacific Islander 
 
 
Black or African American 
 
 
White 
 
 
     More than one race 
 
 
4. Circle the category that best describes your household income?  
 
 
Less than $20,000 
 
$20,000 to $29,999 
 
$30,000 to $39,999 
 
$40,000 to $49,999 
 
$50,000 to $74,999 
 
$75,000 to $99,999 
 
$100,000 or more  
 
 
5. Circle the category that best describes your years of school completed: 
 
Less than high school 
 
High school diploma or GED 
 
Some college 
 
College degree 
 
6. How many total residents are in your home? 
 
 
 
 
 
7.  How many children under 5 reside in your home? 
 
 
 

Page 2 of 2 
If you have more than one child under 5 years of age, please answer the following questions 
starting with the youngest child first:  
 
 
Questions for Child #1 
 
8. Is your child Hispanic or Latino?  
          Age of Child #1 on November 1st:  
 
 
 
Yes 
 
No 
 
9.   What race is your child?  
 
 
American Indian/Alaskan Native  
 
 
Asian 
 
 
Native Hawaiian or Other Pacific Islander 
 
Black or African American 
 
 
White 
 
 
 
 
 
 
More than one race 
 
 
 
Questions for Child #2 
 
10. 
Is your child Hispanic or Latino?                 Age of Child #2 on November 1st:  
 
 
 
Yes 
 
No 
 
11.  
What race is your child?  
 
 
American Indian/Alaskan Native  
 
 
Asian 
 
 
Native Hawaiian or Other Pacific Islander 
 
Black or African American 
 
 
White 
 
 
 
 
 
 
More than one race 
 
 
 
Questions for Child #3 
 
12. 
Is your child Hispanic or Latino?  
        Age of Child #3 on November 1st: _________  
 
Yes 
 
No 
 
13.  
What race is your child?  
 
 
American Indian/Alaskan Native  
 
 
Asian 
 
 
Native Hawaiian or Other Pacific Islander 
 
Black or African American 
 
 
White 
 
 
 
 
 
 
More than one race 
 

Revised October 13, 2014 
HOME CHARACTERISTICS DATA SHEET  
 
 
 
 
Technician:_______________  
Home ID:_________  Winter (1,2,3,etc.):________   
 
 
 
 
Sampling Dates:___________ 
Date form completed:________________ 
 
To be completed by an adult resident once at the beginning of each winter. 
 
1. Number of total residents in home: ___________ 
 
2. Number of residents younger than 18 years of age:  
 
 
 
3. Number of residents younger than 5 years of age:  
 
 
 
4. Type of home: 
House       Mobile Home  
Duplex/Apt 
Other: _____________  
        
5. Year home built:   
 
 
 
 
 
 
 
 
 
 
6. Square footage of home:   
 
     
          
7. Number of floors (not incl. bsmnt): 
1 
2 
3 
 
 
8. Number of windows:  
 
 
 
 
9. Number of bedrooms:  
 
 
    
       
10. Total number of pets:  
 
 
 
 
11. Total number of “furry” pets:  
 
 
 
12. Type of primary heating (Please circle ONLY one choice that represents your most common practice):  
 
     Wood stove      Electrical       Propane       Natural gas furnace   Oil 
Other:   
 
      
       
13. Type of secondary heating (Please circle ONLY one choice that represents your most common practice):   
 
     Wood stove      Electrical       Propane       Natural gas furnace   Oil 
Other:   
 
             
      
14. Existing appliance(s):   Fireplace     Wood stove      Furnace 
 Wood stove insert 
 
15. Wood stove model (If you have access, information is located on the back of the stove): 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16. Approximately how old is your wood stove:  
 
       0-5 years old         6-10 years old 
 11-15 years old 
16 + years old 

Revised October 13, 2014 
17. Is your wood stove EPA-certified?      Yes 
    No     
I don’t know 
 
18. When was the last time you had your chimney cleaned? 
 
      Less than 6 months ago 
   6-12 months ago 
  12-18 months ago 
more than 18 months ago 
 
19. Within the last 12 months have you had wet or damp spots on surfaces inside your home other than in the 
basement (for example on walls, wall paper, ceilings or carpets)? 
 
      Yes 
    No     
I don’t know 
 
20. Has there been mold or mildew on any surfaces inside your home in the last 12 months? 
 
      Yes 
    No     
I don’t know 
 

Child	  Birth	  and	  Infancy	  Data	  
Date:	   	  
	  
	  
	  
	  
Technician:	  	  	  
	  
	  
	  
	  
	  
Home	  ID	  #:	   	  
	  
	  
	  
Child	  ID	  #:	   	  
	  
	  
	  
	  
Date	  of	  Birth:	  	  
	  
	  
	  
Age:	  	   	  
	  
Sex:	  	   	  
	  
Birth	  weight:	  	  
	  
	  
	  
Age	  of	  Mother	  at	  Birth:	  	   	  
	  
Breastfed?	  (circle	  one)	  
	  	  Yes	   	  
No	  
If	  yes,	  for	  how	  long?	  	  
	  
	  
	  
	  
Has	  your	  child	  received	  the	  flu	  shot	  this	  year?	  (circle	  one)	  
	  	  	  Yes	   	  
No	  
	  
If	  not,	  do	  you	  plan	  to	  have	  your	  child	  receive	  the	  flu	  shot?	  	  Yes	   	  
No	  
	  
Does	  your	  child	  attend:	   day	  care	  
preschool/school	  
If	  yes,	  how	  many	  hours/day:	  	  
	  
	  	  	  	  How	  many	  days/week:	  	  
	  
	  
	  
Does	  your	  child	  have	  siblings	  in	  school	  or	  day	  care?	  	  	  
Yes	  
	  
No	  
	  
	  

PARENT/CAREGIVER	  REPORTING	  OF	  SYMPTOMS	  -­‐	  INSTRUCTIONS	  
We	  are	  asking	  you	  to	  help	  us	  in	  monitoring	  the	  health	  of	  your	  child.	  We	  would	  like	  you	  to	  contact	  us	  
immediately	  if	  your	  child	  experiences	  any	  of	  the	  symptoms	  indicated	  below.	  
You	  can	  contact	  us	  through	  one	  of	  two	  ways:	  
1.	  	  
By	  email	  to	  KidsAIR@umontana.edu.	  	  
	  
2.	  
By	  voice	  message	  or	  text	  to	  406-­‐?????	  
	  
As	  part	  of	  your	  email,	  voice	  or	  text	  message	  please	  indicate	  a	  good	  time	  for	  us	  to	  call	  you	  back	  on	  that	  
day	  or	  the	  next.	  	  
	  
PLEASE	  NOTIFY	  US	  IF	  YOUR	  CHILD	  EXPERIENCES	  ANY	  OF	  THE	  FOLLOWING:	  
• 
Fever	  	  
• 
Rapid	  breathing	  
• 
Difficult	  breathing	  
• 
Noisy	  breathing	  
• 
Runny	  nose	  
• 
Cough	  
• 
Wheezing	  
• 
Doctor	  or	  health	  clinic	  visit	  for	  any	  of	  the	  above	  
	  
	  

Procedures	  for	  collection	  of	  child	  health	  measures	  (i.e.,	  respiratory	  rate,	  saturated	  oxygen,	  
temperature).	  Complete	  the	  Child	  Symptom	  Questionnaire	  and	  Health	  Measures	  Visit	  Sheet.	  
1. Make	  sure	  the	  child	  is	  comfortable	  with	  who	  you	  are	  and	  what	  you	  intend	  to	  do.	  	  
2. Explain	  your	  steps	  to	  them	  beforehand	  so	  they	  are	  aware.	  	  
3. Very	  young	  children	  may	  want	  to	  play	  with	  or	  touch	  your	  equipment	  as	  well,	  and	  it	  will	  most	  
likely	  calm	  them	  if	  they	  do.	  Both	  instruments	  are	  rugged	  and	  can	  withstand	  being	  handled	  by	  
them.	  	  
History/Symptoms	  
4. Make	  sure	  you	  have	  your	  Child	  Symptom	  Questionnaire	  handy	  for	  recording	  data.	  
5. Complete	  the	  questionnaire	  and	  record	  symptoms	  as	  stated	  by	  the	  caregiver.	  You	  can	  also	  make	  
note	  of	  symptoms	  given	  by	  the	  child	  if	  they	  offer	  them	  up	  (but	  write	  them	  separately	  so	  you	  
know	  which	  comments	  belong	  to	  whom).	  Record	  any	  important	  personal	  observations	  as	  well.	  	  
Health	  Measures	  
6. Per	  training	  with	  Dr.	  Paul	  Smith,	  complete	  the	  Health	  Measures	  Visit	  Sheet.	  
7. Count	  and	  observe	  respiratory	  rate	  and	  effort.	  	  It	  is	  best	  if	  the	  caregiver	  can	  hold	  the	  child	  on	  
their	  lap	  with	  their	  shirt	  up.	  	  She	  can	  distract	  or	  comfort	  them	  while	  you	  observe.	  Determining	  
respiratory	  rate	  can	  be	  easy	  if	  the	  child	  is	  distracted	  by	  something	  (like	  a	  toy	  or	  TV),	  or	  if	  the	  
child	  is	  sleeping.	  With	  older	  children,	  or	  very	  attentive	  ones,	  it	  can	  be	  harder	  to	  observe	  their	  
breathing	  rate	  without	  them	  noticing.	  If	  the	  child	  knows	  you	  are	  counting	  their	  breaths,	  they	  
may	  adjust	  their	  breathing	  rate	  subconsciously.	  	  A	  good	  trick	  is	  to	  instead	  act	  like	  you	  are	  taking	  
their	  pulse,	  and	  while	  they	  think	  you	  are	  feeling	  for	  their	  heartbeat	  at	  the	  wrist,	  you	  are	  instead	  
subtly	  watching	  them	  inhale	  and	  exhale.	  You	  can	  also	  place	  a	  hand	  flat	  on	  the	  child’s	  upper	  back	  
to	  help	  feel	  inhalations	  and	  exhalations	  better.	  	  
	  
-­‐	  When	  counting	  breaths,	  you	  will	  need	  to	  have	  a	  clock	  nearby.	  	  
-­‐	  Start	  counting	  breaths	  for	  30	  seconds	  and	  remember	  the	  number.	  
-­‐	  Take	  this	  number	  and	  multiply	  it	  by	  2.	  This	  is	  the	  number	  of	  breaths	  per	  minute.	  	  
-­‐	  Record	  this	  observation	  in	  the	  Health	  Measures	  Visit	  Sheet.	  
-­‐	  Also	  note	  any	  retractions	  in	  the	  Health	  Measures	  Visit	  Sheet.	  
	  
8. Now,	  take	  the	  child’s	  temperature	  using	  the	  temporal	  thermometer.	  This	  thermometer	  simply	  
touches	  their	  forehead,	  and	  is	  very	  noninvasive.	  See	  the	  EXERGEN	  Temporal	  Thermometer	  
Protocol.	  
9. Chest	  auscultation	  for	  crackles,	  wheeze	  or	  stridor.	  
10. Determine	  the	  Oxygen	  saturation	  (SpO2)	  in	  the	  blood	  by	  using	  the	  Pulse	  Oximeter	  next.	  	  See	  the	  
Pulse	  Oximeter	  Protocol.	  Do	  this	  last.	  	  Some	  kids	  hate	  it	  and	  crying	  will	  make	  the	  rest	  of	  your	  
exam	  hard.	  	  Also	  record	  the	  pulse	  rate	  (PRbpm)	  off	  the	  SpO2.	  
	  

CHILD	  SYMPTOM	  QUESTIONNAIRE	  
Home	  ID	  #	  
	  
	  
Child	  ID	  #	  
	  
	  
	  
Date:	  
	  
	  
	  
Data	  collected:	  	  	  
By	  phone	  
At	  home	  
In	  the	  last	  two	  weeks	  has	  your	  child	  been	  ill?	  
	  
	  
	  
No	  
	  
Yes	  
	  
If	  yes,	  is	  child	  still	  ill?	  
	  
	  
	  
	  
	  
	  
No	  
	  
Yes	  
	  
	  
	  
	  
Has	  your	  child	  seen	  a	  doctor	  or	  hospital	  or	  nurse	  for	  this	  illness?	  	  
No	  
	  
Yes	  
If	  yes,	  indicate	  person/location:	  	  	  
	  
	  
	  
	  
	  
	  
	  
Note:	  If	  provider	  is	  different	  from	  indicated	  on	  PHI	  form	  collected	  at	  initial	  visit,	  obtain	  a	  new	  parent	  
signed	  PHI	  form.	  
	  
Is	  your	  child	  taking	  any	  new	  medicines	  for	  this	  illness?	  
	  
	  
No	  
	  
Yes	  
Medication	  Names	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
Has	  your	  child	  had	  any	  of	  the	  following:	  
	  
	  
Fever?	   	  
	  
	  
	  
No	  
	  
Yes	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
If	  yes,	  temperature?	  
	  	  	  	  	  °F	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
Indicate	  “N/A”	  if	  unknown.	  
	  
	  
Rapid	  breathing?	  	  
	  
	  
No	  
	  
Yes	  
Difficult	  breathing?	  	  
	  
	  
No	  
	  
Yes	  
Noisy	  breathing?	  	  
	  
	  
No	  
	  
Yes	  
	  
	  
Runny	  nose?	  	  
	  
	  
	  
No	  
	  
Yes	  
	  
	  
Cough?	  	  	  
	  
	  
	  
No	  
	  
Yes	  
	  
	  
Wheezing?	  	  
	  
	  
	  
No	  
	  
Yes	  
[If	  data	  were	  collected	  by	  phone	  and	  child	  is	  currently	  ill,	  schedule	  home	  visit]	  

Health	  Measures	  Visit	  Sheet	  	  
Home	  ID	  #	  
	  
	  
Child	  ID	  #	  
	  
	  
	  
Date:	  
	  
	  
	  
	  
	  
	  
	  
	  
	  	  
	  
	  
	  
	  
	  
Physical	  	  
	  	  	  	  
	  	  	  	  
	  
Referred?	  	  	  	  	  Yes	  	  	  	  	  	  No	  	   	  	  	  	  	  	  If	  yes,	  indicate	  level	  of	  referral:	  	  	  	  	  	  Emergent	  	  	  	  	  	  	  	  	  	  	  Urgent	  	  
	  	  	  	  	  Recommended	  follow	  up	  with	  primary	  care	  provider	   	  
	  
	  
Note:	  For	  an	  Emergent	  or	  Urgent	  referral,	  follow	  referral	  procedures	  and	  then	  contact	  PI	  immediately.	  
	  
	  
	  	  
	  
	  
	  
Lethargy	  
	  
Yes	  	  	  	  	  	  No	  
	  
	  
RR	  	  
(bpm)	  
	  	  	  	  	  	  
Retractions	  
(score)	  
Temperature	  °F	  	  	  	      
Lung	  sounds	  
Wheeze	  
Stridor	  
Crackles	                            
%SpO2	  
Heart	  Rate	  
(PRbpm)	  
AHR	  

EXERGEN	  Temporal	  Thermometer	  Protocol	  
	  
1. Remove	  cap	  from	  the	  end	  of	  thermometer.	  
2. Make	  sure	  metal	  probe	  surface	  is	  shiny	  and	  clean.	  	  
a. If	  not,	  use	  an	  alcohol	  swab	  to	  clean.	  
b. Allow	  to	  dry.	  
3. Place	  probe	  end	  of	  thermometer	  flush	  to	  the	  center	  of	  child’s	  forehead.	  	  
a. Probe	  should	  be	  halfway	  between	  hairline	  and	  eyebrows.	  
4. With	  the	  probe	  placed,	  press	  the	  grey	  front	  button	  and	  hold.	  	  
a. The	  thermometer	  will	  start	  beeping	  and	  a	  red	  LED	  on	  the	  back	  of	  the	  
thermometer	  will	  turn	  on.	  	  
5. With	  the	  button	  still	  depressed,	  slide	  the	  thermometer	  from	  the	  center	  of	  the	  
forehead	  left	  or	  right	  to	  the	  hairline.	  	  
a. Keep	  the	  probe	  moving	  in	  a	  straight	  line—don’t	  follow	  the	  hairline	  
down	  toward	  the	  ear.	  	  
6. Release	  the	  grey	  button	  when	  you	  reach	  the	  hairline.	  
7. Your	  temperature	  measurement	  will	  show	  on	  the	  LED	  display.	  	  
8. Record	  temperature	  on	  Health	  Measures	  Visit	  Sheet.	  	  
9. Clean	  probe	  sensor	  area	  with	  an	  alcohol	  swab.	  
10. Allow	  to	  dry	  and	  reattach	  probe	  cap	  for	  travel.	  
11. To	  switch	  the	  battery,	  remove	  the	  back	  lower	  cover	  and	  exchange	  the	  9V	  square	  battery.	  
	  
	  
	  
	  
	  
	  
	  
The	  thermometer	  will	  turn	  off	  on	  its	  own.	  To	  wake	  it	  back	  up,	  press	  the	  grey	  button	  once.	  The	  display	  
will	  then	  show	  you	  the	  last	  measurement	  taken.	  If	  you	  continue	  to	  hit	  the	  grey	  button,	  it	  will	  scroll	  
through	  the	  last	  eight	  measurements	  taken.	  
*If	  the	  forehead	  has	  perspiration	  present,	  measure	  the	  temperature	  from	  behind	  the	  ear	  instead.	  
1. Instead	  of	  placing	  probe	  on	  center	  of	  forehead,	  place	  it	  on	  the	  neck	  just	  behind	  the	  ear	  lobe.	  	  
2. Press	  and	  hold	  grey	  button	  as	  before	  and	  take	  a	  reading	  while	  keeping	  the	  probe	  
stationary	  in	  that	  spot.	  
	  
	  

Pulse	  Oximeter	  Protocol	  
	  
1. Remove	  blue	  Pulse	  Oximeter	  (pulse-­‐ox)	  from	  blue	  carrying	  case.	  
2. Squeeze	  the	  end	  of	  the	  pulse-­‐ox	  that	  says	  PUSH	  to	  open	  the	  clip.	  
3. Place	  the	  child’s	  index	  or	  thumb	  into	  the	  clip	  and	  release	  the	  
pulse-­‐ox	  so	  it	  gently	  squeezes	  the	  finger.	  
a. The	  child’s	  fingernail	  should	  be	  facing	  up,	  toward	  the	  
display.	  Don’t	  put	  the	  pulse-­‐ox	  on	  upside	  down!	  
b. Make	  sure	  the	  child	  is	  not	  moving	  and	  is	  at	  ease	  during	  
this	  process.	  
4. Press	  the	  white	  button	  on	  the	  top	  and	  it	  will	  turn	  on	  and	  start	  to	  
take	  a	  reading.	  
a. You’ll	  notice	  red	  LED	  lights	  show	  up	  on	  the	  display.	  
b. The	  reading	  will	  take	  a	  few	  seconds	  before	  it	  shows	  up	  on	  the	  display.	  
c. Once	  it’s	  ready,	  you	  will	  see	  two	  numbers:	  
i. The	  first	  number	  will	  appear	  about	  “PRbpm,”	  which	  is	  your	  current	  Heart	  Rate	  
ii. The	  second	  number	  appears	  above	  “%SpO2,”	  which	  is	  your	  oxygen	  percentage.	  
d. Wait	  at	  least	  10	  seconds	  after	  the	  first	  reading	  shows	  up	  before	  you	  record	  the	  
numbers.	  
e. Write	  the	  two	  measurements	  down	  on	  the	  Health	  Measures	  Visit	  Sheet.	  	  
5. Gently	  press	  the	  PUSH	  end	  of	  the	  pulse-­‐ox	  again	  to	  open	  the	  clip	  and	  release	  the	  finger.	  	  
6. The	  pulse-­‐ox	  will	  turn	  off	  on	  its	  own.	  
7. Use	  an	  alcohol	  swab	  to	  gently	  clean	  the	  inside	  of	  the	  clip.	  
8. You	  can	  store	  it	  back	  in	  its	  blue	  carrying	  case.	  	  
	  
9. If	  the	  low	  battery	  icon	  shows	  up	  on	  the	  display,	  you	  need	  to	  switch	  out	  the	  batteries.	  
a. Flip	  the	  pulse-­‐ox	  over	  and	  slide	  off	  the	  blue	  battery	  cover.	  	  
b. Replace	  the	  two	  AAA	  batteries.	  
c. Replace	  the	  blue	  cover.	  
	  
	  
	  
	  
	  

Referral	  Protocol	  
The	  outcomes	  targeted	  in	  the	  KidsAIR	  study	  are	  illnesses	  in	  children	  so	  it	  is	  anticipated	  that	  significant	  
illness	  might	  be	  encountered.	  	  Epidemiologic	  data	  and	  other	  studies	  give	  evidence	  that	  such	  cases	  are	  
few	  but	  ethically	  plans	  should	  be	  in	  place	  for	  field	  workers	  encountering	  them	  (RESPIRE	  studies,	  RSV	  
statistics).	  	  	  In	  keeping	  with	  the	  Presidential	  Commission	  for	  the	  Study	  of	  Bioethical	  Issues	  (Bioethics	  
Commission)	  in	  its	  report,	  Anticipate	  and	  Communicate:	  Ethical	  Management	  of	  Incidental	  and	  
Secondary	  Findings	  in	  the	  Clinical,	  Research,	  and	  Direct-­‐to-­‐Consumer	  Contexts	  
(http://bioethics.gov/sites/default/files/FINALAnticipateCommunicate_PCSBI_0.pdf),	  the	  following	  
outline	  describes	  our	  protocol	  for	  management	  of	  incidental	  illnesses	  in	  the	  subjects	  enrolled	  in	  the	  
KidsAIR	  study.	  
1. The	  medical	  resources	  of	  specific	  areas	  will	  be	  determined	  by	  participating	  investigators	  prior	  to	  
collection	  of	  any	  field	  data	  and	  that	  list	  of	  resources	  will	  be	  provided	  to	  each	  field	  worker	  in	  
anticipation	  of	  emergent	  or	  urgent	  needs.	  That	  list	  will	  include	  local	  Emergency	  Medical	  
Services,	  physicians	  and	  health	  care	  facilities.	  In	  some	  specific	  areas,	  families	  are	  served	  by	  
health	  care	  aides	  or	  nurses	  and	  when	  that	  is	  the	  case	  those	  persons	  will	  be	  the	  first	  contact	  for	  
non-­‐emergent	  cases.	  
2. Local	  healthcare	  providers	  will	  be	  contacted	  prior	  to	  study	  initiation	  and	  made	  aware	  of	  the	  
nature	  of	  the	  study	  and	  intent	  of	  the	  fieldworkers.	  
3. Educational	  sessions	  will	  be	  provided	  to	  each	  field	  worker	  outlining	  signs	  of	  serious	  illness	  for	  
the	  age	  groups	  being	  studied	  (World	  Health	  Organization	  –	  IMCI	  program).	  	  Signs	  of	  illness	  will	  
be	  categorized	  as	  life	  threatening	  (emergent),	  urgent,	  or	  recommended	  for	  scheduled	  
evaluation	  by	  a	  health	  care	  provider.	  	  Each	  category	  of	  illness	  will	  initiate	  a	  different	  level	  of	  
response.	  	  
a. Emergency	  calls	  will	  be	  made	  to	  the	  closest	  available	  emergency	  personnel.	  	  The	  field	  
workers	  will	  stay	  at	  the	  home	  until	  emergency	  personnel	  arrive.	  
b. Urgent	  calls	  (non-­‐emergency	  but	  needing	  care	  in	  less	  than	  24	  hours)	  will	  be	  made	  to	  the	  
primary	  health	  care	  provider	  identified	  by	  the	  parents.	  	  Should	  the	  family	  have	  no	  such	  
provider,	  the	  closest	  emergency	  room	  and	  health	  care	  provider	  will	  be	  contacted.	  
c. For	  illnesses	  that	  do	  not	  require	  emergent	  or	  urgent	  care,	  the	  parents	  will	  be	  advised	  to	  
contact	  their	  health	  care	  provider.	  The	  field	  data	  collector	  will	  volunteer	  to	  help	  families	  
make	  contact	  with	  appropriate	  health	  care	  providers.	  	  A	  phone	  call	  to	  the	  family	  will	  be	  
made	  the	  following	  day	  to	  ensure	  referral	  has	  been	  made.	  
4. The	  field	  worker	  will	  first	  discuss	  concerns	  for	  incidental	  findings	  with	  the	  parent	  or	  care	  
provider	  and	  they	  will	  be	  asked	  if	  they	  have	  a	  health	  care	  provider.	  	  If	  time	  allows,	  that	  person	  
or	  facility	  will	  be	  the	  first	  notified	  of	  possible	  need	  for	  medical	  care.	  	  If	  the	  child	  does	  not	  have	  a	  
primary	  care	  provider,	  a	  list	  of	  possible	  medical	  care	  providers	  or	  institutions	  will	  be	  provided.	  	  
	  
	  
	  

Referral	  Protocol	  (continued)	  
	  
	  
Emergent	  signs	  and	  symptoms	  -­‐	  call	  for	  immediate	  assistance	  to	  911	  local	  EMS	  
Not	  breathing	  
Cyanosis	  (blue	  coloration	  to	  the	  skin)	  	  
Unresponsive	  to	  stimulation	  
Pulseless	  or	  thread,	  weak	  pulse	  
Seizures	  
	  
Urgent	  care	  (call	  to	  local	  health	  care	  aid	  or	  physician)	  
Difficulty	  breathing	  –	  retractions	  involving	  use	  of	  neck	  muscles	  and	  lower	  chest	  
Pulse	  oximetry	  less	  than	  90%	  
Respiratory	  Distress	  –	  wheezing,	  stridor,	  muffled	  voice,	  difficulty	  speaking	  
Coughing	  up	  blood	  
Listlessness	  
Fever	  >	  100.4	  °F	  (<2	  month)	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  >	  102.2	  °F	  (2	  months	  –	  12	  months)	  
	  	  	  	  	  	  	  	  	  	  	  >	  102.2	  °F	  and	  ill	  appearing	  (>12	  months)	  
Active	  bleeding	  
Stiff	  neck	  and	  signs	  of	  mental	  status	  change	  or	  fever	  
	  
Recommend	  follow	  up	  with	  primary	  care	  provider	  within	  the	  next	  day	  
	  
Wheezing	  not	  responsive	  to	  home	  medications	  but	  little	  or	  no	  distress	  
	  
Prolonged	  fever	  (more	  than	  2	  days)	  
	  
Prolonged	  cough	  (>	  3	  days)	  
	  
Prolonged	  illness	  and	  not	  getting	  better	  (>1	  week)	  
	  
	  
	  

Revised October 13, 2014 
HOME CHARACTERISTICS DATA SHEET  
 
 
 
 
Technician:_______________  
Home ID:_________  Winter (1,2,3,etc.):________   
 
 
 
 
Sampling Dates:___________ 
Date form completed:________________ 
 
To be completed by an adult resident once at the beginning of each winter. 
 
1. Number of total residents in home: ___________ 
 
2. Number of residents younger than 18 years of age:  
 
 
 
3. Number of residents younger than 5 years of age:  
 
 
 
4. Type of home: 
House       Mobile Home  
Duplex/Apt 
Other: _____________  
        
5. Year home built:   
 
 
 
 
 
 
 
 
 
 
6. Square footage of home:   
 
     
          
7. Number of floors (not incl. bsmnt): 
1 
2 
3 
 
 
8. Number of windows:  
 
 
 
 
9. Number of bedrooms:  
 
 
    
       
10. Total number of pets:  
 
 
 
 
11. Total number of “furry” pets:  
 
 
 
12. Type of primary heating (Please circle ONLY one choice that represents your most common practice):  
 
     Wood stove      Electrical       Propane       Natural gas furnace   Oil 
Other:   
 
      
       
13. Type of secondary heating (Please circle ONLY one choice that represents your most common practice):   
 
     Wood stove      Electrical       Propane       Natural gas furnace   Oil 
Other:   
 
             
      
14. Existing appliance(s):   Fireplace     Wood stove      Furnace 
 Wood stove insert 
 
15. Wood stove model (If you have access, information is located on the back of the stove): 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16. Approximately how old is your wood stove:  
 
       0-5 years old         6-10 years old 
 11-15 years old 
16 + years old 

Revised October 13, 2014 
17. Is your wood stove EPA-certified?      Yes 
    No     
I don’t know 
 
18. When was the last time you had your chimney cleaned? 
 
      Less than 6 months ago 
   6-12 months ago 
  12-18 months ago 
more than 18 months ago 
 
19. Within the last 12 months have you had wet or damp spots on surfaces inside your home other than in the 
basement (for example on walls, wall paper, ceilings or carpets)? 
 
      Yes 
    No     
I don’t know 
 
20. Has there been mold or mildew on any surfaces inside your home in the last 12 months? 
 
      Yes 
    No     
I don’t know 
 

HOME ACTIVITY LOG 
 
 
Technician:  
Home ID:  
Winter (1,2,3,etc.):  
Sampling Day (1 – 6):  
Sampling Date:  
 
 
 
 
 
 
 
 
To be completed by an adult resident for each day of six day sampling visit. 
 
 
1. Were any of the following heating appliances, other than your woodstove,  
used in the home during the sampling period? 
 
• 
Gas 
 
 
 
No 
 
Yes 
 
• 
Electrical  
 
 
No 
 
Yes 
 
• 
Propane 
 
 
 
No 
 
Yes 
 
• 
Oil  
 
 
 
No 
 
Yes 
 
 
 
• 
Other, specify: 
_________      No 
 
Yes 
 
 
 
 
 
 
 
2. Did any of the following activities or conditions occur in the home during the  
sampling period? 
 
• 
Smoking by anyone in the 
 
home (cigarette, pipe, or other) 
No 
 
Yes 
 
 
• 
Incense burning 
 
 
No 
 
Yes 
 
 
 
• 
Candle burning 
 
 
No 
 
Yes 
 
 
• 
Kerosene/oil lamp  
 
No 
 
Yes 
 
 
• 
Open windows 
 
 
No 
 
Yes 
 
 
• 
Front door propped open   
No 
 
Yes  
  
 
• 
Dusting/sweeping/vacuuming  
No 
 
Yes  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Revised October 6, 2014 

Revised October 13, 2014 
 
 
 
 
 
 
 
 
 
  
WOOD STOVE USAGE LOG 
 
 
 
 
 
 
Technician:  
Home ID:  
Winter (1,2,3,etc.):  
Sampling Dates: 
Date form completed: 
 
To be completed by an adult resident at the end of each six day  
sampling visit. 
 
 
 
 
1. During the sampling period, how would you describe the level of wood burning  
compared to a typical winter day (circle one): 
 
No burning 
Light burning  
Average burning 
Heavy burning 
 
 
 
2. What kind of wood was used or was used most frequently? Please choose ONLY one.  
 
Lodgepole Pine 
 
Ponderosa Pine  
Fir 
 
Larch  
 
 
 
[LIST OTHER COMMON TYPES] _____________________ 
 
 
3. When do you get your wood before burning? (Please circle ONLY one choice that  
represents your most common practice) 
 
A few days 
    
 
 
 
Between 1 week and 1 month  
 
 
Between 1 month and 3 months  
 
Between 3 months and 6 months 
 
Between 6 months and 1 year 
 
 
More than 1year 
 
 
 
4. On average, how many cords of wood do you burn each year?  _________ cords 
 
 
5. How do you usually acquire your wood? (Please circle ONLY one choice that 
represents your most common practice) 
 
 
 
Harvest yourself  
Purchase it 
 
Other:________________ 
  

 
1 
 
 
 
 
 
 
 
 
 
  
IN HOME LOG 
 
 
 
 
 
 
 
Technician:  
Home ID:  
Child ID: 
Winter:  
Sampling dates: 
Sampling start time: 
 
 
 
 
 
 
 
 
To be completed by an adult resident for each participating child for  
each 24 hour period of six day sampling visit. 
 
For each row, please mark the day of week (M, T, W, Th, F, Sa, Su) and whether your child was or 
was not home. If your child was not at home, please mark the circle indicating where your child was. 
 
Age of participating child: _______ 
Child is a:  
girl 
boy 
 
 
Day 
Day of 
week 
Time 
At home? 
If not home, where? 
school 
day 
care 
relative's 
house 
friend's 
house 
other 
1 
  
7:00 AM 
to 
8:00 AM 
Y 
N 
  
  
  
  
  
1 
  
8:00 AM 
to 
9:00 AM 
Y 
N 
  
  
  
  
  
1 
  
9:00 AM 
to 
10:00 AM 
Y 
N 
  
  
  
  
  
1 
  
10:00 AM 
to 
11:00 AM 
Y 
N 
  
  
  
  
  
1 
  
11:00 AM 
to 
12:00 PM 
Y 
N 
  
  
  
  
  
1 
  
12:00 PM 
to 
1:00 PM 
Y 
N 
  
  
  
  
  
1 
  
1:00 PM 
to 
2:00 PM 
Y 
N 
  
  
  
  
  
1 
  
2:00 PM 
to 
3:00 PM 
Y 
N 
  
  
  
  
  
1 
  
3:00 PM 
to 
4:00 PM 
Y 
N 
  
  
  
  
  
1 
  
4:00 PM 
to 
5:00 PM 
Y 
N 
  
  
  
  
  
1 
  
5:00 PM 
to 
6:00 PM 
Y 
N 
  
  
  
  
  
1 
  
6:00 PM 
to 
7:00 PM 
Y 
N 
  
  
  
  
  
1 
  
7:00 PM 
to 
8:00 PM 
Y 
N 
  
  
  
  
  
1 
  
8:00 PM 
to 
9:00 PM 
Y 
N 
  
  
  
  
  
1 
  
9:00 PM 
to 
10:00 PM 
Y 
N 
  
  
  
  
  
1 
  
10:00 PM 
to 
7:00 AM 
Y 
N 
  
  
  
  
  
 
 
 

 
2 
Home ID:  
Child ID: 
Winter:  
Sampling dates: 
Sampling start time: 
 
 
 
Day 
Day of 
week 
Time 
At home? 
If not home, where? 
school 
day 
care 
relative's 
house 
friend's 
house 
other 
2 
  
7:00 AM 
to 
8:00 AM 
Y 
N 
  
  
  
  
  
2 
  
8:00 AM 
to 
9:00 AM 
Y 
N 
  
  
  
  
  
2 
  
9:00 AM 
to 
10:00 AM 
Y 
N 
  
  
  
  
  
2 
  
10:00 AM 
to 
11:00 AM 
Y 
N 
  
  
  
  
  
2 
  
11:00 AM 
to 
12:00 PM 
Y 
N 
  
  
  
  
  
2 
  
12:00 PM 
to 
1:00 PM 
Y 
N 
  
  
  
  
  
2 
  
1:00 PM 
to 
2:00 PM 
Y 
N 
  
  
  
  
  
2 
  
2:00 PM 
to 
3:00 PM 
Y 
N 
  
  
  
  
  
2 
  
3:00 PM 
to 
4:00 PM 
Y 
N 
  
  
  
  
  
2 
  
4:00 PM 
to 
5:00 PM 
Y 
N 
  
  
  
  
  
2 
  
5:00 PM 
to 
6:00 PM 
Y 
N 
  
  
  
  
  
2 
  
6:00 PM 
to 
7:00 PM 
Y 
N 
  
  
  
  
  
2 
  
7:00 PM 
to 
8:00 PM 
Y 
N 
  
  
  
  
  
2 
  
8:00 PM 
to 
9:00 PM 
Y 
N 
  
  
  
  
  
2 
  
9:00 PM 
to 
10:00 PM 
Y 
N 
  
  
  
  
  
2 
  
10:00 PM 
to 
7:00 AM 
Y 
N 
  
  
  
  
  
3 
  
7:00 AM 
to 
8:00 AM 
Y 
N 
  
  
  
  
  
3 
  
8:00 AM 
to 
9:00 AM 
Y 
N 
  
  
  
  
  
3 
  
9:00 AM 
to 
10:00 AM 
Y 
N 
  
  
  
  
  
3 
  
10:00 AM 
to 
11:00 AM 
Y 
N 
  
  
  
  
  
3 
  
11:00 AM 
to 
12:00 PM 
Y 
N 
  
  
  
  
  
3 
  
12:00 PM 
to 
1:00 PM 
Y 
N 
  
  
  
  
  
3 
  
1:00 PM 
to 
2:00 PM 
Y 
N 
  
  
  
  
  
3 
  
2:00 PM 
to 
3:00 PM 
Y 
N 
  
  
  
  
  
3 
  
3:00 PM 
to 
4:00 PM 
Y 
N 
  
  
  
  
  
3 
  
4:00 PM 
to 
5:00 PM 
Y 
N 
  
  
  
  
  
3 
  
5:00 PM 
to 
6:00 PM 
Y 
N 
  
  
  
  
  
3 
  
6:00 PM 
to 
7:00 PM 
Y 
N 
  
  
  
  
  
3 
  
7:00 PM 
to 
8:00 PM 
Y 
N 
  
  
  
  
  
3 
  
8:00 PM 
to 
9:00 PM 
Y 
N 
  
  
  
  
  
3 
  
9:00 PM 
to 
10:00 PM 
Y 
N 
  
  
  
  
  
3 
  
10:00 PM 
to 
7:00 AM 
Y 
N 
  
  
  
  
  
 
 
 
 

 
3 
Home ID:  
Child ID: 
Winter:  
Sampling dates: 
Sampling start time: 
 
 
Day 
Day of 
week 
Time 
At home? 
If not home, where? 
school 
day 
care 
relative's 
house 
friend's 
house 
other 
4 
  
7:00 AM 
to 
8:00 AM 
Y 
N 
  
  
  
  
  
4 
  
8:00 AM 
to 
9:00 AM 
Y 
N 
  
  
  
  
  
4 
  
9:00 AM 
to 
10:00 AM 
Y 
N 
  
  
  
  
  
4 
  
10:00 AM 
to 
11:00 AM 
Y 
N 
  
  
  
  
  
4 
  
11:00 AM 
to 
12:00 PM 
Y 
N 
  
  
  
  
  
4 
  
12:00 PM 
to 
1:00 PM 
Y 
N 
  
  
  
  
  
4 
  
1:00 PM 
to 
2:00 PM 
Y 
N 
  
  
  
  
  
4 
  
2:00 PM 
to 
3:00 PM 
Y 
N 
  
  
  
  
  
4 
  
3:00 PM 
to 
4:00 PM 
Y 
N 
  
  
  
  
  
4 
  
4:00 PM 
to 
5:00 PM 
Y 
N 
  
  
  
  
  
4 
  
5:00 PM 
to 
6:00 PM 
Y 
N 
  
  
  
  
  
4 
  
6:00 PM 
to 
7:00 PM 
Y 
N 
  
  
  
  
  
4 
  
7:00 PM 
to 
8:00 PM 
Y 
N 
  
  
  
  
  
4 
  
8:00 PM 
to 
9:00 PM 
Y 
N 
  
  
  
  
  
4 
  
9:00 PM 
to 
10:00 PM 
Y 
N 
  
  
  
  
  
4 
  
10:00 PM 
to 
7:00 AM 
Y 
N 
  
  
  
  
  
5 
  
7:00 AM 
to 
8:00 AM 
Y 
N 
  
  
  
  
  
5 
  
8:00 AM 
to 
9:00 AM 
Y 
N 
  
  
  
  
  
5 
  
9:00 AM 
to 
10:00 AM 
Y 
N 
  
  
  
  
  
5 
  
10:00 AM 
to 
11:00 AM 
Y 
N 
  
  
  
  
  
5 
  
11:00 AM 
to 
12:00 PM 
Y 
N 
  
  
  
  
  
5 
  
12:00 PM 
to 
1:00 PM 
Y 
N 
  
  
  
  
  
5 
  
1:00 PM 
to 
2:00 PM 
Y 
N 
  
  
  
  
  
5 
  
2:00 PM 
to 
3:00 PM 
Y 
N 
  
  
  
  
  
5 
  
3:00 PM 
to 
4:00 PM 
Y 
N 
  
  
  
  
  
5 
  
4:00 PM 
to 
5:00 PM 
Y 
N 
  
  
  
  
  
5 
  
5:00 PM 
to 
6:00 PM 
Y 
N 
  
  
  
  
  
5 
  
6:00 PM 
to 
7:00 PM 
Y 
N 
  
  
  
  
  
5 
  
7:00 PM 
to 
8:00 PM 
Y 
N 
  
  
  
  
  
5 
  
8:00 PM 
to 
9:00 PM 
Y 
N 
  
  
  
  
  
5 
  
9:00 PM 
to 
10:00 PM 
Y 
N 
  
  
  
  
  
5 
  
10:00 PM 
to 
7:00 AM 
Y 
N 
  
  
  
  
  
    
 
 
 

 
4 
Home ID:  
Child ID: 
Winter:  
Sampling dates: 
Sampling start time: 
 
 
Day 
Day of 
week 
Time 
At home? 
If not home, where? 
school 
day 
care 
relative's 
house 
friend's 
house 
other 
6 
  
7:00 AM 
to 
8:00 AM 
Y 
N 
  
  
  
  
  
6 
  
8:00 AM 
to 
9:00 AM 
Y 
N 
  
  
  
  
  
6 
  
9:00 AM 
to 
10:00 AM 
Y 
N 
  
  
  
  
  
6 
  
10:00 AM 
to 
11:00 AM 
Y 
N 
  
  
  
  
  
6 
  
11:00 AM 
to 
12:00 PM 
Y 
N 
  
  
  
  
  
6 
  
12:00 PM 
to 
1:00 PM 
Y 
N 
  
  
  
  
  
6 
  
1:00 PM 
to 
2:00 PM 
Y 
N 
  
  
  
  
  
6 
  
2:00 PM 
to 
3:00 PM 
Y 
N 
  
  
  
  
  
6 
  
3:00 PM 
to 
4:00 PM 
Y 
N 
  
  
  
  
  
6 
  
4:00 PM 
to 
5:00 PM 
Y 
N 
  
  
  
  
  
6 
  
5:00 PM 
to 
6:00 PM 
Y 
N 
  
  
  
  
  
6 
  
6:00 PM 
to 
7:00 PM 
Y 
N 
  
  
  
  
  
6 
  
7:00 PM 
to 
8:00 PM 
Y 
N 
  
  
  
  
  
6 
  
8:00 PM 
to 
9:00 PM 
Y 
N 
  
  
  
  
  
6 
  
9:00 PM 
to 
10:00 PM 
Y 
N 
  
  
  
  
  
6 
  
10:00 PM 
to 
7:00 AM 
Y 
N 
  
  
  
  
  
7 
  
7:00 AM 
to 
8:00 AM 
Y 
N 
  
  
  
  
  
7 
  
8:00 AM 
to 
9:00 AM 
Y 
N 
  
  
  
  
  
7 
  
9:00 AM 
to 
10:00 AM 
Y 
N 
  
  
  
  
  
7 
  
10:00 AM 
to 
11:00 AM 
Y 
N 
  
  
  
  
  
7 
  
11:00 AM 
to 
12:00 PM 
Y 
N 
  
  
  
  
  
7 
  
12:00 PM 
to 
1:00 PM 
Y 
N 
  
  
  
  
  
7 
  
1:00 PM 
to 
2:00 PM 
Y 
N 
  
  
  
  
  
7 
  
2:00 PM 
to 
3:00 PM 
Y 
N 
  
  
  
  
  
7 
  
3:00 PM 
to 
4:00 PM 
Y 
N 
  
  
  
  
  
7 
  
4:00 PM 
to 
5:00 PM 
Y 
N 
  
  
  
  
  
7 
  
5:00 PM 
to 
6:00 PM 
Y 
N 
  
  
  
  
  
7 
  
6:00 PM 
to 
7:00 PM 
Y 
N 
  
  
  
  
  
7 
  
7:00 PM 
to 
8:00 PM 
Y 
N 
  
  
  
  
  
 

End of Winter Questionnaires 
 
  
Education Homes: 
1. Post winter Questionnaire Education Homes 
2. KAB Education Homes Post Winter 1 & 2 Assessment 
 
Filter Homes: 
1. Post winter Questionnaire Filter Homes 
2. KAB Filter Homes Post Winter 2 Assessment 
 
 
 

Post Winter Questionnaire - Education Homes 
 
Home ID: _____________________ 
 
 
Technician: __________________________ 
Date: ________________________ 
 
Filled out by: 
Mother  
Father  
Other: _____________________ 
Please complete the following brief survey regarding your experiences this winter.  Please circle your response below 
each item. 
 
1. How often did you use the moisture meter during this winter? 
 
Never     Once         Once a Month 
    Weekly 
       Daily 
 
2. Did you split the wood and take the reading from the freshly cut portion of the log? 
 
Yes 
 
No 
 
Not Applicable 
3. How easy has it been to use the moisture meter? 
 
Difficult       Somewhat Difficult          Somewhat Easy 
       Easy 
Not Applicable 
 
4. Has the moisture meter been helpful to you this winter?  
 
Not Helpful 
       Not Very Helpful           Somewhat Helpful          Very Helpful 
 
 
If it was not helpful, can you tell us why? 
___________________________________________________________________________________________
___________________________________________________________________ 
 
5. How often did you use the wood stove thermometer during this winter? 
 
Never     Once         Once a Month 
    Weekly 
       Daily 
 
6. How easy has it been to use the wood stove thermometer? 
 
Difficult       Somewhat Difficult    
Somewhat Easy        Easy 
Not Applicable 
 
7. Has the wood stove thermometer been helpful to you this winter?  
 
Not Helpful 
       Not Very Helpful           Somewhat Helpful          Very Helpful 
 
 
If it was not helpful, can you tell us why? 
___________________________________________________________________________________________
___________________________________________________________________ 
 
8. How often did you use the firestarters during this winter? 
 
Never     Once         Once a Month 
    Weekly 
       Daily 
9. How easy has it been to use the firestarters? 
 
Difficult       Somewhat Difficult    
Somewhat Easy        Easy 
Not Applicable 

 
10. Have the firestarters been helpful to you this winter?  
 
Not Helpful 
       Not Very Helpful           Somewhat Helpful          Very Helpful 
 
 
 
If it was not helpful, can you tell us why? 
___________________________________________________________________________________________
___________________________________________________________________ 
 
 
11. How often did you recall or watch the educational videos during this winter? 
 
Never     Once         Once each Month     Weekly 
     
 
12. How easy has it been to use the guidelines included in the educational videos? 
 
Difficult       Somewhat Difficult             Somewhat Easy        Easy 
Not Applicable 
 
13. Have the guidelines included in the educational videos been helpful to you this winter?  
 
Not Helpful 
       Not Very Helpful           Somewhat Helpful          Very Helpful 
 
 
 
If it was not helpful, can you tell us why? 
___________________________________________________________________________________________
___________________________________________________________________ 
 
 
14. Our staff called you at least once a month throughout the study to check in on your child’s health and to ask a 
few questions about your wood stove. Were these phone calls helpful with troubleshooting issues regarding 
your wood stove? 
 
Not Helpful 
       Not Very Helpful           Somewhat Helpful          Very Helpful 
 
 
If these calls were not helpful, can you tell us why? 
___________________________________________________________________________________________
___________________________________________________________________ 
15. Was there anything new/interesting/helpful that you learned this winter about burning more efficiently and/or 
cleaner with your wood stove? 
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________ 
 
 

KAB - Education Homes - Post Winter 1 & 2 Assessment 
 
Home ID: _____________________ 
 
 
Date: ________________________ 
 
 
Filled out by: Mother  
Father  
Other: ______________________________ 
 
 
The following questions will help us learn more about your woodstove use habits and behaviors.  
There are no “right or wrong” answers to these items. This information will help us understand 
how useful the educational materials and videos were for you this winter.  Please rank the 
following items in terms of how important, helpful, and useful the following suggestions were 
when you used your wood stove the past winter.  
Please rank the items on a scale of 1-4  
(1 = not important at all, 2= not very important, 3 = somewhat important, 4 = very important) 
 
During the past year how important has it been: 
 
 To split your firewood in smaller sizes (6 inches or less in diameter)?  __________  
 To store your firewood in a covered wood pile? 
  
 
    __________  
 To season firewood for 6-12 months before burning?  
 
    __________ 
 To use a moisture meter to test your wood?  
 
 
    __________ 
 To only burn dry, seasoned wood (moisture content <20%)? 
    __________ 
 To maintain a bed of ash just below the vent holes of the wood stove? __________  
 To crack a window/door on the same level when starting a fire? 
    __________  
 To use dry kindling, air movement, and fire starters to help you  
start a hot fire? 
 
 
  
 
 
 
    __________ 
 To allow small hot fires that burn for 20 to 30 minutes to reach  
optimal burn temperatures?   
  
 
 
 
   __________ 
 To use a wood stove thermometer to help you burn at  
specific desired temperatures  
  
 
 
 
   __________ 
 To check your wood stack 20-30 minutes after starting to burn? 
   __________  
 To allow the fire to burn for 20-30 minutes before refueling? 
   __________ 
 To not burn items other than wood (e.g., trash, cardboard, etc.)? 
   __________  
 To clean your flue and chimney? 
 
 
 
 
   __________  
 To condition or dry wood inside for 2 days before burning?  
   __________  
 
To determine wood stove model and locate manual   
 
   __________ 
 
 

Post Winter Questionnaire - Filter Homes 
 
Home ID: _____________________ 
 
 
Technician: __________________________ 
Date: ________________________ 
 
Filled out by: Mother  
Father  
Other: ______________________ 
 
Please complete the following brief survey regarding your experiences this winter.  Please circle your response 
below each item. 
 
1. Did you use your Filter unit this winter? Yes 
  No 
 
 
 
2. Did you use your Filter unit continuously throughout the winter?    Yes 
       No 
 
3. If you did not use your Filter unit continuously, approximately how many hours per week did you have your 
Filter unit turned on?________ 
 
 
4. On what setting(s) did you use your Filter unit when you had it turned on? Please indicate the percentage of 
time on each setting below: 
 
High________ 
Medium________ Low__________  
 
5. If you decided not to use the Filter unit, what were the reasons?  
Noise        Cost 
Appearance               Space Concerns 
    Inconvenience 
N/A 
 
Other ______________________________________________ 
 
Other_______________________________________________ 
 
6. Of the reasons above, which was the most important reason? 
_________________________________________________ 
N/A 
 
7. Overall, do you think the Filter unit has been helpful to you and/or your family this winter? 
 
Not Helpful                  Not Very Helpful                 Somewhat Helpful               Very Helpful 
 
 
 

KAB - Filter Homes - Post Winter 2 Assessment 
 
 
Home ID: _____________________ 
 
 
Date: ________________________ 
 
 
Filled out by: Mother  
Father  
Other: ______________________________ 
 
The following questions will help us learn more about your woodstove use habits and behaviors.  
There are no “right or wrong” answers to these items. This information just helps us understand 
your woodstove usage. Please rank the following items in terms of how important these factors 
are when you have used your wood stove the past two years.  
Please rank the items on a scale of 1-4  
(1 = not important at all, 2= not very important, 3 = somewhat important, 4 = very important) 
 
During the past two years how important has it been: 
 
 To split your firewood in smaller sizes (6 inches or less in diameter)? 
__________  
 To store your firewood in a covered wood pile? 
 
  
 
__________  
 To season firewood for 6-12 months before burning? 
 
 
__________ 
 To use a moisture meter to test your wood?   
 
 
 
__________ 
 To only burn dry, seasoned wood (moisture content <20%)? 
 
__________ 
 To maintain a bed of ash just below the vent holes of the wood stove? 
__________  
 To crack a window/door on the same level when starting a fire? 
 
__________  
 To use dry kindling, air movement, and fire starters to help you  
start a hot fire? 
 
 
 
  
 
 
 
__________ 
 To allow small hot fires that burn for 20 to 30 minutes to reach  
optimal burn temperatures?   
 
  
 
 
 
__________ 
 To use a wood stove thermometer to help you burn at  
specific temperatures?  
 
  
 
 
 
 
__________ 
 To check your wood stack 20-30 minutes after starting to burn? 
 
__________  
 To allow the fire to burn for 20-30 minutes before refueling?  
 
__________ 
 To not burn items other than wood (e.g., trash, cardboard, etc.)? 
 
__________  
 To clean your flue and chimney? 
 
 
 
 
 
__________  
 To condition or dry wood inside for 2 days before burning?  
 
__________  
 To determine wood stove model and locate manual? 
 
 
__________ 
 
 

 
Statistical Analysis Plan 
Analysis was conducted using R version 3.6.2 (The R Foundation for Statistical Computing, Austria). We 
calculated descriptive statistics for continuous variables (n, mean, standard deviation [sd], minimum [min], 
median, maximum [max]) and categorical variables (n, percentage of total) across all study households and 
separately for each treatment arm and study area. We averaged indoor concentrations of PM2.5 over the 6-
day sampling period for each home and for the times during which each child was reported as being at the 
household.  
Primary analyses were conducted within three model frameworks using the lme4 package (Bates et al. 2015): 
1) intent-to-treat (ITT) framework with LRTI outcome (ITT-LRTI), 2) ITT framework with PM2.5 outcome (ITT-
PM2.5), and 3) exposure-response (ER) framework with LRTI as the outcome and PM2.5 as the exposure of 
interest. Although LRTI cases were collected as count data, very few children had more than one LRTI, 
resulting in under-dispersed data that violated the assumptions of attempted Poisson and negative binomial 
regression models. Thus, the ITT-LRTI framework utilized mixed effects logistic regression models (using the 
glmer function) with presence of LRTI (yes or no) as the outcome and assigned treatment as the exposure of 
interest. The ITT-LRTI models included a covariate for person-time at risk to account for the wide variability of 
child-weeks at risk across study participants. The models also included a covariate for child age (<1 year vs. 1 
to 4 years) since randomization occurred within strata of this term. A nested random term (i.e., 
household:cohort:area) was included in the model to account for repeated measures clustered within 
household, cohort, and study area. The ITT-PM2.5 framework used mixed effects linear models (using the lmer 
function) with mean 6-day indoor PM2.5 concentration as the outcome and assigned treatment as the 
exposure of interest. Models were adjusted for child age and included a nested random term of cohort:area 
(there were no repeated measures within household for PM2.5). Both ITT models utilized the study’s 
randomization and were not adjusted for potential confounding variables in the primary analyses.  
The ER framework utilized mixed effects logistic regression models (using the glmer function) with presence of 
LRTI (yes or no) as the outcome and mean 6-day indoor PM2.5 concentration as the exposure of interest. As 
with the ITT-LRTI models, ER models were adjusted for person-time at risk and included a nested random 
term (i.e., household:cohort:area) to account for repeated measures in the analysis. In addition, since the ER 
models did not utilize the study’s randomization to help control for confounding, covariates were included in the 
model to adjust for potential confounders. Confounders were identified a priori through previous literature and 
by assessing independent associations with the exposure and outcomes of interest (Adaji et al. 2019; Mortimer 
et al. 2017; Noonan et al. 2019; Smith et al. 2011; Walker et al. 2021). We also used directed acyclic graphs 
(DAGs) to assess the direction and potential relationship between indoor PM2.5, LRTI, and covariates (Figure 
S3). Final ER models were adjusted for child age and sex, caregiver race and sex, household income, 
caregiver education, if a household resident smoked, and ambient temperature and PM2.5.  
The primary ITT model framework was prespecified in our previously published methods paper (Noonan et al. 
2019). We conducted a number of sensitivity analyses in all model frameworks that were specified a priori 
(during the initial model development when the analyst was masked to treatment arm assignment) and 
assessed the impact of including potential confounders in the models and using subsets of the data. We 
conducted sensitivity analyses by including potential confounders that had some imbalance across study arms 
(ITT frameworks) or by including additional potential confounders not included in the primary model (ER 
framework). Due to the different control treatment in AK (no filtration unit), we conducted the ITT-LRTI and ITT-
PM2.5 analyses with AK households excluded from the dataset. For the ITT-LRTI and ER frameworks, we also 
conducted a sensitivity analysis with a dataset restricted to Winter 1 only, as this was the only winter of 
observation when indoor PM2.5 was sampled. For the ER framework we conducted an additional sensitivity 
analysis that used indoor PM2.5 when each child was at home as the primary exposure variable in place of 
indoor PM2.5 over the entire sampling period.  
We also conducted some post hoc sensitivity analyses for the ITT-LRTI framework with other model variations 
to provide insight into our primary model selection and results. Specifically, we assessed models that 1) used 

study area (AK, NN, WMT) as a fixed effect rather than a random nested term, 2) removed the covariate for 
person-time at risk, and 3) removed the random nested term for household.  
We evaluated potential modification of the effect of the treatments by a priori selected child, caregiver, and 
home characteristics within each of the model frameworks by including interaction terms in the primary model. 
We assessed significance of the interaction terms using Type II Wald Chi-square tests. Model assumptions 
were evaluated in all analysis frameworks. Indoor PM2.5 concentrations were natural-log transformed in the 
ITT-PM2.5 framework, and estimates are presented as percent difference in geometric mean PM2.5.