Clinical trial NCT04614974
Conditions: Laryngomalacia Gastro Esophageal Reflux
Keywords: Laryngomalacia Symptom improvement Famotidine Speech Language Therapy
Sponsor: Reema Padia
Start date: 2020-11-18; Completion date: 2024-05-17
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. The investigators recently performed a retrospective chart review assessing improvement of airway and dysphagia symptoms, weight gain, and need for surgery with AST. It was found that there was a similar improvement between LM severity groups and most patients received AST (96.6%). It is unclear if these improvements are due to AST or natural resolution of the disease. With heightened concerns of side effects related to AST in infants, particularly among those born prematurely, judicious use of these medications is needed. The investigators are now performing a prospective study looking at the outcome differences in patients with laryngomalacia who are evaluated by speech language therapy (SLP) alone versus those with SLP evaluation and acid suppression therapy (famotidine).

Detailed description:
Purpose: To determine the outcome differences in patients 6 months and younger with laryngomalacia and dysphagia who are evaluated by speech language therapy (SLP) alone versus those with both SLP evaluation and acid suppression therapy (AST) (famotidine)

Hypothesis: There will be no differences in outcomes between those that had SLP alone versus those that had both SLP and AST.

Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression therapy (AST) has been empirically used in the management of this disorder. However, there is no gold standard in treating mild and moderate LM patients and therefore this study will help establish guidelines for treatment.

A medical chart review will be performed to assess airway and dysphagia symptom improvement from consult to the 3-month follow up appointment and then up to a year. The Pittsburgh Airway Symptom Score (PASS) questionnaire and the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) will be given to families at the consult and at the 3-month follow up appointment for caregiver assessment. The physician will then perform the standard procedures at the clinic appointment. The Flexible Laryngoscopy Findings sheet will be filled out in conjunction with the clinic procedures for objective data. The surveys will then be scored to determine true GERD (score \>=16) and severe laryngomalacia (LM) (RED questions on the PASS), which would further exclude these patients. There are 12 total questions on the I-GERQ-R. On the PASS, questions 1 \& 2 are in the GREEN category and signifies mild LM, YELLOW signifies moderate LM, and RED is severe LM. On the PASS questionnaire, "Yes" to either #1 or #2 and nothing else is mild LM, "yes" to at least one #3-5 and none of #6-10 is moderate LM, and "yes" to any of the #6-10" indicates severe LM. There are 10 total questions on the PASS. Mild and moderate LM patients will be block randomized the day before the appointment to receive speech language therapy alone or speech language therapy with famotidine (Pepcid). Both treatments are standard of care in these patients. Speech language therapy (feeding therapy) is part of the normal clinic visit for LM patients. These patients will then be re-evaluated at their follow up appointment in 3 months (+/- 1 month). The families will take the PASS and I-GERQ-R surveys again to determine LM severity.

Initially, primary outcome #2 was "Dysphagia symptom score change from consult (baseline) to 3 month follow-up appointment." This is the same as the original secondary outcome measure #6 "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment" (I-GERQ-R is the dysphagia symptom score used in this study). Therefore, these were consolidated to a single primary outcome measure "Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) score change from consult (baseline) to 3 month follow-up appointment." This change was made after study and data collection completion, at the time of results reporting.

Arms: arm 1: Patients in this group will receive a routine swallowing evaluation by a speech language pathologist. Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment. arm 2: Patients in this group will receive a routine swallowing evaluation by a speech language pathologist and famotidine (acid suppression therapy). Patient caregivers will fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) and the Pittsburgh Airway Symptom Score (PASS) the day of the appointment and at the 3-month follow up appointment.
Interventions: intervention 1: Famotidine intervention 2: Speech Language Therapy
Intervention descriptions: intervention 1: Famotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language. intervention 2: Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.

Protocol documents:
Prot_SAP_000.pdf: 
Page 1 of 7 
 
Study Protocol  
 
 
 
 
 
 
Official Title: Initiation of Acid Suppression Therapy Prospective 
Outcomes for Laryngomalacia 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT04614974 
 
 
 
Protocol Date: 05/14/2021 
 
 
 
 


Page 2 of 7 
 
Scientific Background 
 
Laryngomalacia (LM) is the most common cause of stridor in infants. Symptoms of 
gastroesophageal reflux (GER) are often seen in the setting of LM; therefore, acid suppression 
therapy (AST) has been empirically used in the management of this disorder. Our team recently 
performed a retrospective chart review assessing improvement of airway and dysphagia 
symptoms, weight gain, and need for surgery with AST. We have found that there was a similar 
improvement between LM severity groups and the majority of patients received AST. It is 
unclear if these improvements are due to AST or natural resolution of the disease. With 
heightened concerns of side effects related to AST in infants, particularly among those born 
prematurely, judicious use of these medications is needed. We are now performing a prospective 
study looking at the outcome differences in patients with laryngomalacia who are evaluated by 
speech language therapy (SLP) alone versus those with SLP evaluation and AST. There is no 
gold standard in treating mild and moderate LM patients and therefore this study would help 
establish these guidelines. 
 
Study Objectives 
 
Purpose: To determine the outcome differences in patients 6 months and younger with 
laryngomalacia and dysphagia who are evaluated by speech language therapy (SLP) alone versus 
those with both SLP evaluation and acid suppression therapy (AST) 
 
Hypothesis: We hypothesize that there will be no differences in outcomes between those that had 
SLP alone versus those that had both SLP and AST. 
 
Study Design & Methods 
 
Design: Prospective clinical trial with survey 
 
Methods: 
 
All Department of Pediatric Otolaryngology Airway clinic patients with a referral diagnosis of 
laryngomalacia will have their medical records screened for eligibility. All eligible families with 
infants that qualify for the study will be approached the day of clinic by their licensed physician 
to discuss the study. They will be given the Pittsburgh Airway Symptom Score (PASS) 
questionnaire and the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) at the 
beginning of the appointment. The physician will then perform the standard procedures at the 
clinic appointment. The Flexible Laryngoscopy Findings sheet will be filled out in conjunction 
with the clinic procedures for objective data. The surveys will then be scored to determine true 
GERD (score >=16) and severe laryngomalacia (LM) (RED questions on the PASS), which 
would further exclude these patients. There are 12 total questions on the I-GERQ-R. On the 
PASS, questions 1 & 2 are in the GREEN category and signifies mild LM, YELLOW signifies 
moderate LM, and RED is severe LM. On the PASS questionnaire, "Yes" to either #1 or #2 and 


Page 3 of 7 
 
nothing else is mild LM, "yes" to at least one #3-5 and none of #6-10 is moderate LM, and "yes" 
to any of the #6-10" indicates severe LM. There are 10 total questions on the PASS. 
Mild and moderate LM patients will be block randomized the day before the appointment to 
receive speech language therapy alone or speech language therapy with famotidine (Pepcid). 
Both treatments are standard of care in these patients as well as watchful observation. Speech 
language therapy is part of the normal clinic visit for LM patients. There is no gold standard of 
care for LM, therefore this trial is important to establish this. Patients will be randomized in both 
mild and moderate LM blocks before the appointment, as providers are unaware of the severity 
until the time of the appointment. After the appointment, if the family does not want to 
participate, the name will be taken off the randomization sheet completely or off the unused 
block. 
 
These patients will then be re-evaluated at their follow up appointment in 1 to 4 months. The 
families will take the PASS and I-GERQ-R surveys again to determine LM severity. If Pepcid is 
discontinued due to intolerance of side effects, they will be kept in the study in the same arm. If 
the family opts out of the follow-up appointment or they do not need to follow-up in-person, 
families will take the post surveys via REDCap or by mail. A REDCap link will be sent along 
with a letter to the caregivers to the caregivers' email address on file. If the families do not fill 
out the surveys within 2 weeks, paper copies of the surveys along with a letter to the caregivers 
will be sent to the caregivers' home address on file. If the families do not return the paper copy or 
the electronic copy of the surveys, researchers will call the participants for a reminder and will 
ask if the family wants another paper copy or survey link. The family may also answer the 
survey questions over the phone. 
 
Eligibility Criteria  
 
Inclusion:  
 Pediatric patients ages 0 to 6 months who do need meet the criteria at the initial 
appointment for supraglottoplasty 
 Seen in UPMC CHP Otolaryngology Department 
 Laryngomalacia without prolonged (>20 seconds) cyanosis, apnea, nor failure to thrive. 
 
Exclusion: 
 Children over the age of 6 months old will be excluded from participation. 
 Premature infants (<37 weeks gestation) 
 Patients with lung disease. 
 Laryngomalacia with cyanosis, apnea, and failure to thrive 
 Sleep induced laryngomalacia 
 Patients with craniofacial abnormalities 
 Patients with a syndrome 
 Patients with additional airway abnormalities, seen before or at consult 
 Patients with symptoms that necessitate surgery 
 Patients with prior cardiac surgery 
 Patients with AST prescribed prior to the initial ENT consult. 
 


Page 4 of 7 
 
 
 
 
 
Statistical Analysis Plan 
 
 
 
 
 
 
Official Title: Initiation of Acid Suppression Therapy Prospective 
Outcomes for Laryngomalacia 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT04614974 
 
 
 
Protocol Date: 05/14/2021 
 
 


Page 5 of 7 
 
Study Objectives 
 
Aim: To determine the outcome differences in patients 6 months and younger with 
laryngomalacia and dysphagia who are evaluated by speech language therapy (SLP) alone versus 
those with both SLP evaluation and acid suppression therapy (AST) 
 
Study Outcomes 
 
Primary Outcome 
 Airway Symptom Score Change From Consult (Baseline) to 3 Month Follow-up 
Appointment.  
o This will be parent-reported and measured using the Pittsburgh Airway Symptom 
Score (PASS) questionnaire. The PASS is a scale from 0-10 with a higher score 
indicating a worse outcome. This outcome will be assessed at the consult and the 
3 month follow-up appointment. 
 Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) Score Change From Consult 
(Baseline) to 3 Month Follow-up Appointment.  
o This will be parent-reported. There are 12 questions on the surveys on a scale of 
0-42. A higher score indicates a worse outcome. Those with a score of >=16 on 
this survey at the initial consult are excluded from the study, indicating true 
gastroesophageal reflux disease (GERD). This outcome will be assessed at the 
consult and the 3 month follow-up appointment. 
 Change in Incidence of Airway Symptoms From Consult up to 1 Year Assessed Via 
Electronic Medical Chart Review.  
o Change in incidence of airway symptoms from consult up to 1 year assessed via 
electronic medical chart review. Notes from the Department of Otolaryngology 
will be reviewed which include reported symptoms from caregivers and 
symptoms seen upon exam. Airway symptoms included periods of apnea, chest 
wall retractions, cyanosis, stridor, noisy breathing, and increased respiratory rate. 
 Change in Incidence of Dysphagia Symptoms From Consult up to 1 Year Assessed Via 
Electronic Medical Chart.  
o Change in incidence of dysphagia symptoms from consult up to 1 year assessed 
via electronic medical chart review. Notes from the Department of 
Otolaryngology will be reviewed which include reported symptoms from 
caregivers and symptoms seen upon exam. Dysphagia symptoms included 
choking, coughing, gagging with feeds and/or emesis after feeds. 
 
Secondary Outcomes 
 Weight (kg) From Consult up to 1 Year.  
o Weight change in kilograms assessed from medical chart review from consult up 
to 1 year 
 Number of Participants With the Need for Supraglottoplasty Surgery (Escalation of 
Treatment) up to 1 Year.  
o The need for escalation of treatment with supraglottoplasty surgery will be 
assessed through medical chart review up to 1 year. 


Page 6 of 7 
 
 Number of Participants With the Need for Acid Suppression Therapy Medication 
(Famotidine) From Speech Language Therapy Alone Group From the Day After the 
Consult up to the 3 Month Follow up Appointment.  
o The speech language therapy alone group will be assessed for the need for a 
prescription for acid suppression therapy (famotidine) from the day after the 
consult up to 1 year. 
 Number of Participants With Each Type of Laryngomalacia (Types 1-3) Found on the 
Flexible Laryngoscopy Procedure at the Consult.  
o All patients will be scoped with a flexible laryngoscopy at the initial consult and 
the type of laryngomalacia (Types 1-3) will be noted. 
 Number of Participants With the Need for a Different Acid Suppression Therapy 
Medication (Other Than Famotidine) From the Day After the Consult up to the 3 Month 
Follow up Appointment.  
o Both groups will be assessed for the need for a different acid suppression therapy 
medication (other than famotidine) from the day after the consult up to the 3 
month follow up appointment. 
 
Sample Size Calculation 
 
Based on data from Dang et al [1], 62 participants per group will be needed to address the 
hypothesis that there is no difference in airway symptom improvement between AST and no-
AST groups with alpha=.05 and power=.80 (two-tailed Fisher's exact test, G*Power 3.1). Target 
enrollment will be 160 participants (80 in the AST group and 80 in the no-AST group, with 40 
with mild laryngomalacia and 40 with moderate laryngomalacia in each group) to account for 
attrition. 
 
[1] Dang S, McCoy JL, Shaffer AD, Tobey ABJ, Dohar JE, Simons JP, Maguire RC, Padia R. 
Initiation of acid suppression therapy for laryngomalacia. Am J Otolaryngol. 2022;43(3):103434. 
doi:10.1016/j.amjoto.2022.103434 
 
 
 


Page 7 of 7 
 
Analyses 
 
Stata/SE 16.1 will be used for all statistical analysis.  
P value < .05 will be used for statistical significance.  
 
Baseline characteristics will be compared between AST and no-AST groups using Chi-squared 
or Fisher’s exact test for categorical data and t-test (normally distributed) or Wilcoxon rank-sum 
(not normally distributed) for continuous data. Primary outcome measures will be change in 
LASS and I-GERQ-R scores from initial visit to follow-up and change in airway and dysphagia 
symptoms assessed by chart review during the 1 year following the initial visit. The LASS and I-
GERQ-R scores will be compared between initial and follow-up surveys using Wilcoxon signed-
rank tests. Change scores (post-pre) will be calculated for LASS and I-GERQ-R, and differences 
in the improvement in scores based on laryngomalacia severity or randomization group will be 
evaluated using Wilcoxon rank-sum tests. Associations between LASS or I-GERQ-R and time 
between initial and follow-up surveys will be evaluated using Spearman rank correlation. 
Symptoms and weight at initial and follow-up visits will be compared using McNemar’s and 
Wilcoxon signed-rank tests, respectively. Change in weight percentile based on laryngomalacia 
severity or randomization group will be evaluated using Wilcoxon rank-sum tests. 
 
Cross-Over 
Intent-to-treat analysis will be performed. 
 
Analysis Inclusion  
Only those who meet eligibility criteria will be included in the final analysis. Specific outcome 
measures will be ascertained only in patients who complete follow-up questionnaires, as 
indicated.  
 
Missing Data 
Data imputation will not be used for missing data.  
 
Harms 
 
Serious adverse events and non-serious adverse events resulting in emergency department visits 
will be collected up until 1 year following the initial consult appointment.  

ICF_001.pdf: 
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CONSENT TO BE PART OF A RESEARCH STUDY
Study Title: Initiation of Acid Suppression Therapy Prospective Outcomes for Laryngomalacia
Principal Investigator: Reema Padia, MD. Reema.Padia@chp.edu
Research Coordinators: Amber Shaffer, PhD, CCRP. 412-692-6874. shafferad@upmc.edu
    Marina Rushchak. 412-692-9879. rushchakmv4@upmc.edu
Co-Investigators: Sophia Dang, MD; Joseph Dohar, MD; Raymond Maguire, DO; Jeffrey Simons, MD;     
Allison Tobey, MD; Kristin Cangilla, MS, CCC-SLP
What is the purpose of this research study?
●
This study will help show if an acid reducer medication (famotidine or Pepcid) that is sometimes given to
babies for laryngomalacia (LM) helps improve symptoms. We recently found there was a similar improvement
between mild and moderate LM in patients who were on acid reducer medication and in patients who were
not on acid reducer medication. However, since most infants were on an acid reducer medication, it is
uncertain if these improvements are due to the medication or the natural resolution of LM.
●
160 patients will be randomly assigned (like flipping a coin) to be in either:
A. prescribed famotidine (Pepcid) and receive speech language therapy (feeding therapy)
B. or receive speech language therapy (feeding therapy) alone
●
Participation is completely voluntary. It will not affect your child’s care if you do not participate in the study.
●
Speech language therapy (feeding therapy) with or without an acid reducer medication is the most common
treatment for mild or moderate LM.
Who is being asked to participate in this study?  
●
160 caregivers and their baby (6 months of age or younger) with mild or moderate laryngomalacia
What is the compensation or payment for participation?
●
There is no compensation for participation.
What are my child and I being asked to do?
●
You will be informed at your consult appointment if your child qualifies for the study based on symptoms and
the scope performed.
●
You will be asked to fill out the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) with 12 questions
and the Pittsburgh Airway Symptom Score (PASS) with 10 questions at the consult and the follow-up
appointment in 1 to 4 months.
●
If your child qualifies for the study, they will be randomly assigned to receiving speech language therapy
(feeding therapy) with or without famotidine (Pepcid). This means there is an equal change of either getting
or not getting the famotidine (Pepcid). This medication is FDA-approved and is currently used to treat
symptoms of laryngomalacia in children.
●
Based on which group your child is randomly assigned to, you will be provided instructions on the dose of
medication for your child
●
Your child will also see a speech-language pathologist (SLP) on the day of your child’s appointment.
●
The study will not pay for your medications – you would purchase these medications just as you would if you
were not enrolled in this study.
●
You will be asked to give your child the medicine prescribed. Please consult your child’s doctor with any
change in medication or if you believe your child should stop taking the medication. The decision to prescribe
any medication will be up to your child’s physician.
Department of Otolaryngology
UPMC Children’s Hospital of Pittsburgh 
One Children’s Hospital Drive
4401 Penn Avenue
Pittsburgh, PA  15224


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●
You will be asked to return to your child’s Ear, Nose, and Throat (ENT) doctor in 1 to 4 months to check on 
your child. Please call the scheduling number provided or make a follow-up appointment at the consult.
●
If you do not have a follow-up appointment for your child in 3 months, you will be sent an email to the email 
address on file with a link to take the two surveys (I-GERQ-R and PASS) electronically about your infant’s 
current symptoms. If the surveys are not filled out electronically, a paper copy of the surveys will be mailed 
two weeks after the email to your home address on file with a postage paid envelope to return to the research 
office. If the surveys are not returned from the email link or paper copy, a researcher will call you to follow-
up. You may take the surveys over the phone at this time or request another survey link or paper copy.
●
For all medical questions please call the ENT nurse line at 411-692-5460, option 4 or send your doctor a 
virtual message. 
●
Neither you, nor your insurance, will be charged for this research. You will be charged for any procedures 
performed for your child’s routine medical care.  
What are the risks and benefits of participating in this research study?
●
The medication being evaluated in this study is famotidine (Pepcid). Pepcid is a Histamine-2 blocker that 
works by lowering the amount of acid the stomach produces by blocking the histamine receptors 
(Pepcid.com).
●
Some babies suffer from acid reflux. The benefit of taking famotidine (Pepcid) is to prevent more inflammation 
in your child’s airway.
●
The infrequent risks of famotidine (Pepcid) include worsening airway or dysphagia (swallowing) symptoms, 
increased risk for necrotizing enterocolitis (NEC), bone fractures, agitation or irritability, headache, vomiting, 
somnolence (drowsiness), anorexia (loss or lack of appetite for food), candidiasis (yeast fungal infection), 
and/or the inability to tolerate the medication. To decrease the risk of complications, give the medications as 
prescribed.
●
Speech language therapy (feeding therapy) will be provided by a speech-language pathologist (SLP) at the 
consult appointment. The benefit of having this evaluation is to assess if your child has a swallowing or 
feeding disorder and will identify a treatment for adequate nutrition and optimal feeding. The infrequent risks 
include choking and the inability to tolerate a change in feeding (bottle nipple change).
●
As with any research study involving a medicine, there may be problems or side effects that are currently 
unknown. Some of these unknown risks could be permanent, severe, or life-threatening. You will be quickly 
notified if any new information we learn during this research study may cause you to change your mind about 
continuing to participate.
●
The risk of collecting private health information may be a breach of confidentiality. We will do everything 
possible to protect your privacy and confidentiality, but no method of electronic storage is perfectly safe; 
therefore, absolute confidentiality cannot be guaranteed.
●
The risks of completing surveys are breach of confidentiality, feeling uncomfortable answering the questions, 
and finding them cumbersome.
What are the alternatives to my child participating in this study? 
●
The alternative to participating is to follow the advice of and/or work with your child’s doctor for LM 
management. 
What should I know about the medical information you will be using?
●
We are also asking for your authorization for the researchers listed at the top of this document to look at your 
child’s medical records. We will look for things like age, race, zip code, insurance, primary language, 
diagnoses, ENT clinic information, ENT-related outcomes and any complications. This is needed to measure 
any differences in those taking famotidine (Pepcid) or not. This authorization is good for an unlimited amount 
of time.
Who will know that my child is in this research study?
●
All physicians recruiting for the study and the researchers listed on the top of this form will know that your 
child is in this research study. Representatives from the UPMC Children’s Hospital of Pittsburgh will have 
access to the medical record, including for billing and auditing purposes. The University of Pittsburgh Office 
of Research Protections may review your child’s identifiable research information to make sure this study is 


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being done correctly. In unusual cases, the investigators may be required to release identifiable information 
related to your child’s participation in this study in response to an order from a court of law. If we learn that 
your child or someone with whom they are involved is in serious danger or potential harm, we will inform the 
appropriate agencies. De-identified medical information may be shared with researchers who are conducting 
similar research.  A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required 
by US law. This website will not include information that can identify you or your child. At most, the website 
will include a summary of the results. You can search this website at any time. However, you will not be 
notified about your child’s individual research results.
How will my child’s privacy rights be protected?
●
A possible risk is that someone not on this form may see your child’s information. However, paper records 
will be in a locked file in a locked office. Also, electronic information will be kept on a password-protected 
computer behind the UPMC firewall. 
●
Electronic records will be de-identified with linkage codes to help protect confidentiality.
●
Per University of Pittsburgh policy, all research records must be maintained at least 7 years following final 
reporting or publication of a project. For projects involving children, records must be maintained for 5 years 
past age of majority (age 23 per PA state law) after study participation ends. 
What happens if I decide that I no longer want my child to be in this study?
●
At any time, you can decide to no longer be a part of the study. You can withdraw your authorization for us 
to use your child’s identifiable medical information. To formally withdraw your consent for participation in this 
research study, you should provide a written and dated notice of this decision to the principal investigator of 
this research study at the address listed on the first page of this form. Withdrawing from this study will not 
affect your child’s care.  When your child reaches age 18, your permission is no longer valid. 
Can the study physician decide my child should no longer participate in the study? 
●
A study physician may decide that your child should not continue in the study for safety or other healthcare-
related reasons. An example might be if she or he has an allergic reaction to the medication, or if there are 
other significant side effect or risks to your child’s health from the medication. Another reason would be if the 
physician decides your child would benefit from surgical intervention to treat LM.
Who should I contact with medical questions?
●
If you have any medical questions, you may contact the ENT department at Children’s Hospital at 412-692-
5460 and select option #4 to speak with a nurse. For all medical emergencies, call 911.   
●
If you think that the research procedures have resulted in an injury to you, immediately contact the Principal 
Investigator who is listed on the first page of this form. Emergency medical treatment for injuries solely and 
directly related to your participation in this research study will be provided to you by the hospitals of UPMC. 
Your insurance provider may be billed for the costs of this emergency treatment, but none of those costs will 
be charged directly to you. If your research-related injury requires medical care beyond this emergency 
treatment, you will be responsible for the costs of this follow-up care. At this time, there is no plan for any 
additional financial compensation. You do not, however, waive any legal rights by signing this form.


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VOLUNTARY CONSENT
The above information has been explained to me and all of my current questions have been answered. I 
understand that I am encouraged to ask questions about any part of this research study at any time. I understand 
that I may contact the University of Pittsburgh Human Subjects Protection Advocate of the IRB office (866-212-
2668) to discuss problems, concerns, and questions.
By signing this form, I agree to participate in this research study by having my child be randomized into a 
treatment group. I authorize the research team to look at my child’s medical records.  A copy of this consent form 
will be given to me. 
 PARENTAL CERTIFICATION
_______________________________________             ________________________________________
               Printed Name of Your Child                                          Your Relationship to Participant (Child)
I understand that, as a minor, the above-named child is not permitted to participate in this study without my 
consent; therefore, by signing this form, I give my consent for his/her participation in this research study. 
____________________________    ______________________________    ________________________
            Parent’s Signature                                Parent’s Name (Print)
                           Date         
                        
INVESTIGATOR CERTIFICATION
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), 
and I have discussed the potential benefits and possible risks of study participation. Any questions the 
individual(s) have about this study have been answered, and we will always be available to address future 
questions, concerns or complaints as they arise. I further certify that no research component of this protocol was 
begun until after this consent form was signed. 
______________________________________              ___________________________________
     Printed Name of Person Obtaining Consent                                             Role in Research Study
________________________________________                 _______________________________________
         Signature of Person Obtaining Consent                                                      Date and Time