Interventions to Help Infants and Children Recover in the Hospital
Phase: NA
Conditions: Infant Apnea, Neonatal Abstinence Syndrome, Sleep
Sponsor: Elisabeth Salisbury, PhD

NCT03881553 Study Protocol and Statistical Analysis Plan 
 
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Elisabeth B. Salisbury, Ph.D. 
 
NCT03881553: Interventions to Help Infants Recover in Hospital 
 
Study Protocol and Statistical Analysis Plan v.071020 
 
Document Date 07/10/20 
 
 

NCT03881553 Study Protocol and Statistical Analysis Plan 
 
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1. TITLE 
NCT03881553: Interventions to help children recover in the hospital.  
 
2. EXTERNAL IRB REVIEW HISTORY* 
N/A 
 
3. PRIOR APPROVALS: 
 
Conflict of Interest (COI):   
The PI (Salisbury) is a co-inventor on a patent for the stochastic vibratory stimulation 
(SVS) mattress device, which will be used in this project. There is an approved mitigation 
plan in place at UMass due to a potential financial conflict of interest.  
COI Mitigation Approval Letter uploaded on eirb. 
 
Clinical Engineering Department: 
Medical and research devices with power sources will be inspected for safety, including 
grounding and minimal current leakage as necessary, prior to being placed in service and 
will be inspected annually by the Clinical Engineering Department. The Clinical 
Engineering Department Electrical Safety Inspection protocol shall be used as the 
inspection procedure. All measurements shall meet the NFPA 99, IEC 60601 healthcare 
standards for electrical safety. All medical devices with power sources regardless of 
ownership shall be inspected for safety, including grounding and minimal current leakage 
as necessary, prior to being placed in service.  
 
Upon receiving new equipment with power sources for use in the study, a study 
investigator will notify the Clinical Engineering Department at 508-334-1111 directly, or 
through the Materials Management Department, regardless of the purchase rental, loan, 
lease, evaluation, or demonstration arrangement. The outside manufacturers/ contractors 
are responsible for the quality and performance of all rented, leased, contracted, or 
equipment on evaluation.  
 
Biohazardous Agents: 
• N/A 
  
Radiation: 
• N/A 
 
4. PROCEDURES INVOLVED 
Randomization: Subjects will participate in up to four study sessions that include 
NEATCap intervention and/or SVS mattress intervention based on duration of subject’s 
hospitalization, availability of research personnel, availability of device and fit-ability of the 
device around the head and ears of the subject (currently we have 4 sizes, but additional 
sizes may become available during the study period). Subject will serve as his/her own 
control, and will receive alternating periods of intervention ON vs intervention OFF.   

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• Devices: Purpose of use and regulatory approval status (see also section 32). 
The two experimental devices used in this study are Abbreviated IDEs: 
 
1) NEATCap Device: The NEATCap (“Dreamies”) device is an experimental device 
engineered by NEATCap, LLC (patent pending). It is a circumaural passive noise 
protection device comprised of a soft fabric headband with a specially-designed 
ear covering that simulates the acoustic filtering of a pregnant mother’s body. The 
device was designed to dampen unsafe, high frequency noises (e.g., alarms from 
medical equipment) while allowing passage of low frequency sounds such as a 
caregiver’s voice. There are no electrical components to this device. The device is 
a circumaural hearing protector, FDA product code EWE [510(K) exempt device], 
which as per FDA rulings does not require IDE to test before the device is 
marketed; 
see: 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=E
WE]. The predicate device for NEATCap “Dreamies” is MiniMuffs Neonatal Noise 
Attenuators, marketed by Natus Medical since 1995 that has been used on NICU 
infants in high-noise situations for many years. Indications for use state “The 
device is intended for use on newborns to provide reduction in the sound level 
reaching the newborn’s ears.” The proposed studies in this docket involves non-
invasive measurements with NEATCap device, also an EWE circumferential 
hearing protector device, for up to four session periods, not to exceed 24 hours in 
any one period.  
 
2) SVS Mattress Device: The SVS mattress device is an experimental device. It 
will be used to gently stimulate the subject. The specially-constructed mattresses 
are similar to the usual hospital mattress except that inside the mattress foam there 
is a device that vibrates the foam, controlled by an external unit. The mattresses 
are constructed by Cofab Design, LLC or other contracted company using patent 
specifications, modified to adjust for various size cribs and beds. The device 
components in the mattress and external control unit may be modified with 
improved technologies to allow for testing of various displacements and mattress 
sizes, and to help ensure consistency of mattress integrity over time. The 
mattresses are designed so that the foam vibrates throughout the entire mattress. 
We are aware of no deleterious effects of the SVS mattress. We have studied over 
100 premature infants (since 2001) and over 50 infants exposed to opioids in utero 
(since 2010) using the SVS mattress without incident or apparent side effects. The 
FDA has not approved the SVS mattress as a treatment for prematurity or 
withdrawal. Sound level produced by the mattress will be monitored and will not 
exceed 75 decibels (60-70 dB is normal conversation; 75 dB is about the sound of 
an average car interior on a highway). The UMass/Memorial Health Care 
Biomedical Engineering will certify the electrical safety of the mattress devices. 
 
• Research procedures: Subjects will participate in up to four sessions, applying 
either the NEATCap and/or SVS mattress. Sessions will last on average between 
8 and 12 hours, and will not exceed 24 hours in any one session. All sessions will 

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be performed at the subject’s NICU/CCN or PICU/PIU bedside. Infants and 
children enrolled in this study will receive routine, standard of care, which may 
include pharmacological management as prescribed by their primary medical 
caregiver complementary to the intervention (NEATCap; SVS mattress). Nurses 
are instructed to provide routine care and to intervene as they would typically do 
despite the presence of an investigator by the bedside. 
 
Standard measurements and recordings. Physiologic recordings with and 
without electroencephalographic (EEG) activity will be obtained through state-of-
art acquisition system (e.g., Embla, Nihonkohden or other) obtained (hardcopy) or 
recorded (digital) directly from hospital monitor (e.g., Philips, ixTrend or other). 
Respiratory inductance plethysmography (RIP) will be used to measure breathing. 
Respiratory belts will be placed around the chest wall and/or abdomen to record 
respiratory muscle movements, and allow for detection of inter-breath intervals 
(IBI) of respiration. Sensors over the skin surface of the torso will be used to record 
electrocardiographic activity (ECG), and allow for detection of R-R intervals of the 
ECG signal (index of inter-beat heart rate). Electrodes over the head and face area 
will be used to measure EEG activity at the surface of the cortex to allow for sleep 
stage classification using EEG signal analysis; electrode impedance will be 
measured to help ensure data quality. A probe attached to the foot or wrist will 
measure arterial-blood oxygen concentration; quality of the plethysmographic 
activity characterized in the pulse signal will allow for identification of movement 
periods. Movement periods will be assessed further via actigraphy with a wireless 
sensor worn around the infant’s leg and/or arm that records limb movement. Skin 
temperature will be measured continuously with a sensor placed under the armpit 
or back. A sound and light meter placed near the head will record sound frequency 
and intensity, and changes in light level. Overt behavioral data will be recorded 
using a camera with a wide-angled lens placed within or near the subject’s bed. 
Medical history (including toxicology screens) and demographic data will be 
obtained on the infant/child and on the biological mother by manual medical record 
review or electronically extracted via UMCCTS Data Lake. 
 
Data acquisition, recording and archival. Physiological data will be digitally 
recorded (~50-1kHz samples per channel) using bedside data acquisition system 
or recorded directly from hospital bedside monitor onto secure research 
computer/laptop. Acquisition systems enable fully synchronized recordings of 
physiological signals, audiometry, photometry and digital video images. 
Comments regarding routine nursing assessments and other relevant information 
(e.g. feeding, pharmacological dosing) will be typed and time stamped along with 
the physiological data stream. Movement will also be digitally recorded 
independent of the full-acquisition system using wireless actigraphy sensor. All 
signals, video images and germane data (e.g., medical histories) will be stored on 
encrypted, password protected computers. Investigators will also manually record 
relevant study information (timing and mode of experimental conditions, nursing 
assessments, feeds, medications etc) on log sheets. A log (computer or pen and 
paper) of the infant’s/child’s daily activities and nursing interventions will also be 
obtained, along with relevant clinical information (feeds, withdrawal scores, 
medications) obtained from electronic medical record for the study session day 

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and up to one day preceding and following each study session.  
 
Study Sessions. The study will be conducted in the UMass Memorial 
NICU/CCN and in the UMass Memorial Children’s Medical Center PICU/PIU. The 
subject will be studied in the unit in which he/she is receiving care. Enrollment in 
this study allows the subject to participate in up to 4 full-recording study sessions 
throughout their hospitalization. A full-recording study session will typically last 
approximately 8-12 hours (~8am-6pm or ~8pm-6am); some sessions may start 
earlier/later or go shorter/longer and in some instances we may study the subject 
for 24 hours (based on research personnel and equipment availability). The 
reasoning behind a shorter session and for having morning and evening start times 
is that as the subject matures, s/he may have ‘wakeful’ periods that prevent study 
in the crib/bed for certain periods throughout the day. The reasoning behind a 24-
hr period is if we have available research-personnel support, we may study a 
subject throughout a complete 24-hr period to obtain diurnal responses. The 
number of full-recording sessions the subject participates will depend on duration 
of hospitalization (e.g., some subjects may be in the hospital longer than others, 
which will allow more opportunity to participate in multiple study sessions), on 
availability of research equipment and research personnel, and parent/guardian 
schedule (e.g., parent/guardian may prefer we not study the subject on certain 
days, for example if they want to spend time holding the subject or have visitors 
throughout the day). We will review the infant’s/child’s medical records and we will 
obtain 
additional 
history 
through 
questionnaire 
from 
the 
consenting 
parent/guardian. We will also obtain medical history on the subject’s biological 
mother, including questionnaire and review of maternal medical records, if 
available through the UMass Memorial Healthcare system. 
 
Sessions will begin during the infant’s/child’s feeding, assessment or wake 
period, during which time sensors for the full-physiology/polysomnography 
recording will be applied by research study staff; sessions may begin any time if 
recordings are obtained directly from the bedside monitor. Periods of no 
intervention (NEATCap device OFF or SVS Mattress OFF) will be alternated with 
periods of intervention on (NEATCap device ON or SVS Mattress ON). The 
duration of each intervention period will conform to the routine care of the study 
subject. Because feeds vary as a function of subject’s age, for example premature 
infants are typically on a fixed ~every 3-4 hours, whereas older infants and children 
may feed ad-libitum (i.e., as the child desires), the duration of intervention ON and 
OFF will vary within and between sessions and among subjects. The hospital 
standard of care for an individual subject, and the subject’s sleep/wake cycle will 
determine the duration of the intervention periods. For subjects who may sleep 
throughout the night, periods of intervention will conform to either a routine 
assessment or medication interval (typically ~ every 3-4 hours) to allow for 
comparisons between intervention ON and intervention OFF with minimal 
disruption to the subject. The OFF-ON alternating cycles allow subjects to serve 
as their own control and ascertain if intervention ON leads to consistent, positive 
responses in the same subject, and assess whether the effect changes over the 
period.  
 
NEATCap Intervention: At feed/assessment/wake period preceding a 

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NEATCap ON period, the NEATCap device will be fitted and placed on the child 
by research study staff. The NEATCap device will be removed (OFF) and replaced 
(ON) at alternating intervals throughout the study session. Physiological data will 
be recorded throughout the session while the subject is in the crib/bed or hospital-
issued sleeping environment (e.g., motorized seat). 
 
SVS Mattress Intervention: At the start of the study session (during a 
feed/nursing intervention/wake period), the subject’s hospital mattress will be 
replaced or covered with the SVS mattress. For bedside studies in babies cared 
for in infant crib-warmers that have low guard walls, SVS mattress bedframe 
extenders (Cofab Design, LLC) will be attached to the guard walls of the infant 
crib-warmers for the duration of the study session. These bedframe extenders will 
extend the guard wall 2 inches, the height difference between the SVS mattress 
and the standard crib-warmer mattress. The study staff will turn the external 
mattress controller off (SVS Mattress OFF) and on (SVS Mattress ON) at 
alternating periods throughout the study session. Physiological data will be 
recorded throughout the session while the subject is in the crib/bed with the SVS 
mattress. 
 
• Data to be Collected: Infant/Child subject and biological maternal medical histories 
including maternal drug use during pregnancy (if applicable), infant/child daily 
clinical care measurements (feeds, medications, withdrawal scores), and analyzed 
data (i.e., scored sleep studies; actigraph and physiological data) comprise the 
data obtained from subjects. Data may be obtained directly from infant/child 
medical record, maternal medical record, and/or questionnaire administered to 
person/s providing informed consent. All data will be collected solely for the 
proposed research studies.  
 
• Medical record review: Subject’s medical records will be reviewed and additional 
history will be obtained from parent/guardian, including review of biological mother 
medical records if in the UMass Memorial medical record system. We may review 
medical records throughout the infant’s/child’s hospitalization and for up to 1-year 
post hospital discharge. Study staff may review medical records for information 
pertinent to this study enrollment period until the study is closed out. We request 
protected health information from general medical records and review of statutorily 
protected records at this institution to: 1) Make sure the infant/child meets inclusion 
criteria; 2) Obtain toxicology reports indicating drugs of exposure and other 
relevant records pertaining to NAS and/or iatrogenic drug withdrawal; 3) Obtain 
information about factors that may influence the physiological function of the 
infant/child (e.g., prenatal and postnatal care and prenatal drug exposures; critical-
care illness for which the child is being treated in the NICU/PICU, and post-
discharge followup). We request to review both the infant’s/child’s and mother’s 
medical records for information from cardiac studies, nursing and respiratory 
therapy notes, clinical monitor information, intake and discharge summaries, daily 
assessments (feeds, medications, withdrawal scores), EEG/EMG studies, 
laboratory results, operative procedures, conclusive pathologies, clinical problem 

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list, and pulmonary, radiology and rehabilitation information. Data collected will be 
stored on REDCap forms. 
 
• Covid-19 Related Procedures: 
 
In accordance Joint UMCCTS_IRB Covid-19 Guidance v2 031720, we restricted 
human subjects-related research as follows:  
 
 
1. Halted enrollment 
 
 
2. Halted all in-person bedside studies 
 
 
 
 
As per IRB and CCTS Guidelines and Job aid for reopening human subjects’ 
research during the Covid-19 pandemic, the following procedures will be 
employed upon IRB approval to resume in-person research studies to help 
ensure the safety of study participants and their families, research staff, and 
personnel involved in the care of the infant throughout study enrollment. 
 
Research study staff will comply with ongoing Institutional Covid-19 requirements 
and adhere to unit safety precautions.  
 
Approval has been obtained from study safety officers and medical caregivers in 
clinical departments to resume studies in infants’ respective units where the 
bedside studies are conducted with the following procedures: 
1. Recruitment: We will continue to identify subjects through medical record 
(HIPAA waiver in place) and obtain approval from subject’s medical caregiver 
within the subject’s unit department for approaching candidates who meet 
criteria. Any known COVID-19 positive patients will be excluded from study.  
2. Consent of new study subjects: Given that infant-subjects are in-hospital at 
time of consent, in-person consents will be obtained via current process with the 
following additional Institutional recommended Covid-19 safety measures by 
research staff: e.g., social distancing, masks, hand-washing. Writing pens will be 
wiped with Institutional-hospital cleaning/sterilizing wipes before and after 
obtaining each hard-copy signature. Remote consenting procedures as per Job 
Aide for reopening humans subjects’ research guidelines may be used in 
instances when study staff is unavailable to consent in person (e.g., Due to 
Covid-19 Institutional restrictions on number of personnel allowed in office on a 
given workday, research personnel with consenting privileges may not be on site 
at a time conducive to obtaining timely consents). Verbal informed consents in 
hospital may be conducted via electronic video-chat/zoom/call, and may be 
obtained from subject by research staff within the consenting time frame. Hard-
copy signatures will be obtained from the subject and researcher obtaining 
consent, or by another researcher with consenting privileges who subsequently 
reviews the consent with the subject in person prior to start of any intervention.  
3. Bedside Studies: We will follow Institutional unit Covid-19 safety protocol for 
cleaning/sanitizing bedside study equipment, devices, and sensors that are not 
disposable (e.g., mattress, study cables, bedside laptops, ipads, actigraph, 
pens). We will abide by all unit safety precautions for infant and adult 
participants, including caregivers who have in-patient privileges with the in-
patient infant. For adult subjects/caregivers who are in hospital and participating 

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in study questionnaires on behalf of themselves and/or their infant at the bedside, 
research staff will comply with all unit safety requirements. Questionnaire testing 
materials (e.g., pens, ipads, clip boards) will be cleaned before and after use with 
hospital sanitizing wipes. Adult subjects will wear gloves while completing 
paper/electronic questionnaires. Research staff will comply with unit safety 
measures, e.g, mask, gown and glove, during bedside sessions, in addition to 
routine hand washing and hand sanitizing. 
5. DATA AND SPECIMEN BANKING* 
REDCap will be used to store research data stored as subject code (PHI such as 
infant/child and maternal medical histories, daily clinical care measurements) and 
analyzed data (i.e., scored sleep studies; actigraph and physiological data). Physiological 
and environmental (light/sound) data collected on acquisition system and actigraph data 
may also be stored on excel worksheets on password protected computers for post-hoc 
analysis.  
 
It is possible that the data will be shared with collaborating investigators (e.g., engineers 
and programmers) to assist with signal processing and analysis, with the NEATCap 
device manufacturer and/or other manufacturers who may be involved with the 
development or commercialization of either devices, and investigators not associated with 
this project. If so, all data will be stripped of all identifiers (anonymized) and subjects’ 
identity will be unknown to these personnel. De-identified information may be made 
available in the future for the research community using NIH-sponsored websites, in 
accordance to NIH mandated data sharing policy. Any investigator contacting us for such 
data will be directed to the appropriate website(s), which has detailed instructions on the 
use of the data in accordance with NIH policies. Subject may choose to have research 
data anonymized at any time during or at the end of the study by contacting Dr. Elisabeth 
Salisbury at 508-334-8627 (or via email at Elisabeth.salisbury@umassmed.edu). 
 
• Disclosure of Research Results: This study is for research purposes only. 
Individual results will not be given back to study participants nor will individual 
results go into subjects’ medical record. In the short term, we do not anticipate that 
any clinically or diagnostically important information can be learned from this 
research, although such information could eventually be forthcoming.  
 
6. DATA ANALYSIS AND MANAGEMENT* 
Statistical Procedures and Power Analysis. 
 
Study design will allow systematic quantification (mean and variance) of the effects of 
NEATCap device and SVS mattress on automatic function, such as breathing (IBI), 
cardiac rhythm (R-R), frequency and duration of body movements (e.g., defined via 
streamlined video, artifact in pulse-oximeter plethysmographic activity, and actigraph 
count), blood oxygenation (e.g., durations<85%), skin temperature, and sleep states. 
Analyses will be conducted to determine whether interventions impinge on neural 
oscillators that drive breathing and cardiac control, and whether NEATCap device 
reduces dangerous levels of environmental noise, to improve autonomic function and 
sleep activity.  

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Signal processing algorithms will be used to characterize separately the instability of 
physiological signals, such as respiration and heartbeat. We will explore, for example, 
whether different durations of movement periods (e.g., 1.5-5 sec; >5 sec; >10sec) have 
unique relationships with withdrawal (NAS or iatrogenic) or prematurity, and are affected 
differently with different interventions (NEATCap device and SVS Mattress).  
 
Parametric tests will be used for analyses of all continuous variables.The Friedman’s 
and Wilcoxon signed-rank tests will be used for nonparametric analyses. For analyses of 
parametric data separate repeated measures ANOVAs will test effects of stimulus 
condition (ON or OFF) and trial order. Post-hoc pairwise t-tests will determine differences 
in responses for conditions of stimulation ON and OFF. For example, separate repeated 
measures ANOVAs will test effects of stimulus condition (ON or OFF) and trial order on 
physiological variables. Time of intervention (e.g., infant age, severity of NAS) will be a 
covariate to assess whether there are critical periods in infant development for optimizing 
the intervention as a therapeutic strategy. Pearson product-moment correlation 
coefficient analysis will be used to establish associations between breathing stability (IBI 
variance) and movement duration, with the expectation that greater variance in 
respiratory parameters will be positively correlated with excessive movement. P values 
of <0.05 will be considered significant. 
 
The number of periods and duration of intervention will not always be the same for 
each study session. The proposed study will test if different modes (NEATCap; Mattress 
SVS) affects duration of the interfeed interval, improves autonomic function, and 
promotes sleep. This is a within-subjects design, so all subjects will receive intervals of 
routine clinical care in addition to the assigned intervention/s complementary to routine 
care. Intervention assignment for study session is based on equipment availability, 
research personnel availability; it will not be determined by the subject’s treating 
physician.  
• It is possible that a subject does not receive an intervention (participate in a study 
session) after enrollment if: 1) We have technical difficulties and are unable to 
conduct studies; 2) Subject is discharged before being entered into an intervention 
stimulation session; 3) Doctor treating child requests we terminate the study – we 
will heed to the discretion of the Attending Physician or primary medical caregiver 
for decisions regarding termination of an infant from the study for example due to 
sickness, sepsis or exacerbated withdrawal symptoms (e.g., seizures) –  such 
population of subjects will likely already be excluded by the exclusion criteria, but 
others unknown at this time may also ensue. Medical criteria for terminating a 
subject from the study will be determined by the medical caregiver treating the 
infant. Authorized parent, nurse or investigator may stop/postpone a study session 
for reasons such as excessive symptomatology preventing ability to properly study 
the subject (e.g., unable to keep sensors in place, infant needs to be held 
incessantly, skin rash), parent has visitors or simply doesn’t want an infant/child 
studied on a particular day – this would not result in termination from the study per 
se. If we find that a mode of stimulation appears to make the infant/child irritable 
(e,g., excessive waking, crying, movement), we will end the study session for that 
day. If this happens on a second study-session day, we will discontinue study. 
 
7. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 

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An independent medical safety monitor will review serious adverse events reported to  
the IRB and will summarize each in a written report that will be submitted to the Center 
for Advancing Point of Care Technologies (CAPCaT) for any required reporting to NIH. 
 
This research does not involve more than minimal risk to subjects. While it may be difficult 
to determine whether NEATCap or SVS mattress causes worsening of physiological 
function or is related to common system dysregulation of the subject, a study may be 
discontinued at any time if the investigators or the subject’s medical caregiver suspects 
there are any adverse effects on breathing, heart rate, thermoregulation, oxygenation, 
movement or any other function. 
 
Nurses are instructed to provide routine care and to intervene as they would typically do, 
e.g., in the event of a prolonged apnea, bradycardia or blood-oxygen desaturation, 
despite the presence of an investigator by the subject’s bedside. The protocol may be 
ended if intervention is associated with noticeable exacerbation of irritability including 
disproportionate awakening, cardio-respiratory instabilities, and/or excessive rise in 
temperature as observed by a medical caregiver, researcher, or parent at bedside during 
a study session. Parent/Guardian or medical staff may terminate the study (subject 
withdrawn) or request not to part-take in any procedure/s at any time (subject remains in 
study). Our studies are conducted at the bedside so we are in frequent contact with the 
clinical staff; we will routinely seek informal feedback from the medical-care staff to ensure 
the safety of our study protocols. The medical-care staff and parent/guardian are 
encouraged to call us if they have any specific concerns throughout the study enrollment. 
 
• Confidentiality and Data Management: In all research records, reports and 
publications of the study data (including medical history and physiological signals) de-
identified alpha-numeric study code will identify the subject. This code will be kept in 
a central database on a password protected PC. Username and password are 
required to unlock all research-related computers; additional passwords are used for 
files containing the study code that identify the subjects and de-identified data files. 
Only research study staff will have access to the identifying file. Any hard-copy data 
will identify subjects only by study code, and will be kept in a locked file cabinet. We 
may share de-identified data with other collaborating investigators, individuals or 
companies/entities in order that they may assist us with signal processing, analysis 
and interpretation The authorized parent/guardian may choose to have the research 
data anonymized at any time of the study; it will not be possible to destroy data that 
has already been used in analyses and data for investigational devices is required to 
be maintained under FDA regulations.  
 
To help protect subject privacy, a Certificate of Confidentiality (COC) has been issued 
by the National Institutes of Health in accordance with NIH COC Policy (NOT-OD-17-
109; 
see 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html; 
and 
https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.4_confidentiality.htm). 
With 
this Certificate, researchers cannot be forced to disclose information that may identify 
a study subject, even by a court subpoena, in any federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings. This Certificate allows the 

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researchers to resist demands for identifying information with the following exceptions: 
1) The Certificate does not prevent investigators from mandate reporting to health 
officials certain communicable diseases required by state law or local law; 2) The 
Certificate does not prevent investigators from reporting to authorities any knowledge 
of child or elder abuse, and/or intent to hurt oneself or others. The Certificate cannot 
be used to resist a demand for information from the US Government that is used to 
audit or evaluate federally funded projects. There is also information that must be 
disclosed to the FDA. Infants at risk for NAS due to exposure to drugs in utero are 
identified to the study investigators by physicians treating the infants. The infant’s 
medical team is responsible for relevant mandatory reporting.