Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity
Phase: NA
Conditions: Preterm Birth
Sponsor: Augusta University

 
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Protocol Title: Early Fortification of Human Milk for Very Low Birth Weight 
Infants and Effects on Growth Velocity  
Principal Investigator: Zanna Wynter, DO 
1. Objectives 
Describe the purpose, specific aims, and hypothesis: 
 
The purpose of this investigation is to determine whether early fortification of human milk feeds 
improve growth outcomes for very low birth weight infants (VLBW) (birth weight 1000-1500 
grams). We hypothesize that introducing higher caloric feeds at the onset of enteral feeds will 
improve early growth metrics in VLBW infants as compared to infants who begin human milk 
fortification after the first week of life, which represents our present standard of care. The primary 
outcome for this study is growth velocity (g/kg/day) at 28 days of life. 
 
2. Background 
Describe the background and rationale for the study: 
Human milk, maternal or donor milk, is the standard of care for feeding premature infants. However, 
human milk alone does not provide sufficient energy, protein, fat, and micronutrients to meet the demands 
of the VLBW premature infant. Thus, slow growth can persist for preterm infants and catch-up growth can 
be incomplete even after discharge from the NICU, and slow extra-uterine growth (weight, length, and 
head circumference) is associated with poor neurodevelopment and lower intelligence in school age 
children born preterm. Using human milk fortifiers (HMF) increase nutrient density of human milk and 
allows for infants to maintain a human milk-based diet, which has been shown to reduce the incidence of 
necrotizing enterocolitis (NEC) and improve cognitive outcomes in preterm infants.  
   Fortification of human milk is institution-specific and no standard of care has been recommended 
regarding the timing of fortification of human milk feeds in preterm infants. Much of the concern for 
earlier fortification arise over whether comorbidities, such as NEC and feeding intolerance, will be more 
prominent in infants provided early fortification versus delayed fortification. To date, no studies have 
demonstrated a relationship between human milk fortifiers and the incidence of NEC or feeding tolerance. 
Thus, delays in introducing HMF may represent an unwarranted safety concern that interferes with 
supplying an appropriate nutrient-enriched diet to preterm infants. For example, 34.3% of preterm infants 
are diagnosed with post-natal growth failure at the Children’s Hospital of Georgia. Further, later 
introduction of HMFs may lead to longer time to reach full enteral feeds, total duration on total parental 
nutrition (TPN), or duration of central venous line use. Current available evidence suggests that 
fortification of human milk starting at the first feed is safe and well-tolerated and may have substantial 
benefit for preterm infant growth.  
 

 
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3. Inclusion and Exclusion Criteria 
List the inclusion/exclusion criteria: 
Inclusion:  
1. Birth weight 1000-1500 grams  
2. Admitted to AU NICU within 24 hours of life  
3. Maternal intent to use human milk (maternal or donor milk) 
Exclusion:  
1. Congenital anomalies including congenital heart disease or other major defect requiring surgical 
intervention  
2. Feeds not started within first 96 hours of life  
3. Intrauterine growth restriction (IUGR) defined as <3rd % on a gender specific Fenton growth curve  
 
4. Number of Subjects/Records/Samples Collected 
Indicate the total number of subjects to be accrued/records reviewed/samples collected across all sites: 
 
5. Recruitment Methods 
Describe when, where, and how potential subjects will be recruited: 
All neonates admitted to the NICU who have a birth weight of 1000-1500 grams will be eligible for 
this study. Screening will include chart review to ensure inclusion criteria is met. Parents (legal 
guardians) of eligible neonates will be approached for study participation by the PI or co-
Investigators.  
 
The sample size was determined assuming an alpha level of 0.05, power of 80%, a common 
standard deviation of 3.64, and a two-sided two-sample t-test to examine differences in weight 
growth velocity at 28days between the two feeding protocol groups.  The mean for the standard of 
care group (fortification beginning on day 8) was 10.6% and for the intervention group 
(fortification beginning on day 1) was 12.3, 12.6 and 13.6.  The sample size required for each mean 
difference is below 
 
Assumed Mean in Each Group 
 Sample Size 
2. per Group 
Fortification Day 8 
Fortification Day 1 
10.56 
12.25 
74 
10.56 
12.56 
53 
10.56 
13.56 
25 
 
A sample size of 25 per group, for a total of 50 subjects will be needed. 

 
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6.   Multiple Site                                                                ☒ N/A                                                             
7. Reliance Agreements/Single IRB                                ☒ N/A                                                             
 
8. Procedures Involved 
a. Describe the procedures involved to include those procedures that are standard evaluation 
and/or care and those that are solely for research purposes: 
Feeding Protocol 
All VLBW infants in AU’s NICU are provided a standard feeding protocol that has been in 
use since 2011 and includes fortification of human milk with Enfamil High Protein Liquid 
Human Milk Fortifier (HP HMF) on feeding day 8. Study participants will be randomly 
assigned to receive standard of care (ie fortification on feeding day 8) or fortification on 
feeding day 1. In general, feedings for preterm infants are started in the first 48 hours.  
b. Describe and explain the study design: 
If the study involves multiple conditions where each condition involves different procedures, 
please provide a table that breaks down the procedures by condition and in chronological 
order. Include when and where they are performed. 
1. Subjects will be randomly assigned to one of two groups using blocked randomization to 
ensure equal allocation throughout enrollment. Blocks of size 4 and 6 will be randomly 
determined and then the group assignment will be randomly permuted within each 
block. Initiation of enteral feedings, enteral volume advancement, and weaning off 
parental nutrition will follow the standardized NICU feeding protocol.  
2. Subjects will be fed a diet of human milk per standard NICU feeding protocol. Should 
maternal milk supply be inadequate to meet daily volume needs, donor milk will be used 
per standard NICU feeding protocol. Importantly, mothers (or guardians) must provide 
written consent for donor human milk. This consent is separate from the study consent 
and will be required for study participation. 
3. Enfamil High Protein Liquid Human Milk Fortifier (HP HMF) will be used to fortify 
maternal milk.  
4. Parenteral nutrition will be provided as outlined in the standard NICU feeding protocol 
and will be consistent with parenteral intake provided to all VLBW infants in the NICU 
regardless of study participation.  
5. Enfamil HP HMF will be added to provide 22 calories/ounce on the initiation of enteral 
feeds for the intervention group (feeding day 1). For the control group, Enfamil HP 
HMF will be added to provide 22 calories/ounce when enteral feeding volume reaches 
80 mL/kg/day (feeding day 8). Caloric density will be advanced to 24 calories/ounce at 
feeding day 10 for both groups. The caloric density progression follows the standard 
NICU fortification practices.  
 
Blinding Procedures 

 
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Feeding tolerance is largely subjective. As an important secondary outcome, we will blind all 
healthcare personnel to study group allocation for the first 7 feeding days.  
1. Upon consent, participants will be randomized to one of two study groups.  
2. The milk bank in the NICU is responsible for all human milk preparation. Milk bank 
technicians will receive the group allocation for each participant and prepare human 
milk with/without fortification according to standard formulations.  
3. Group allocation for each participant will be recorded by milk bank technicians on the 
daily feeding sheets (standard procedures for all infants). Group allocation and 
fortification will be confirmed by one study member of the study team who will be 
unblinded (co-Investigator Canfield who is the NICU dietician that oversees the milk 
laboratory). 
4. Blinding will be accomplished by removing the caloric content from the label for all 
study participant. In the field that contains calories, “study participant” will be entered. 
Blinding will occur during the first 7 feeding days and calorie content will be recorded 
on feeding day 8 and all subsequent feeding days. 
Intervention Group 
 
Parenteral Nutrition/IV Fluids  
 
Enteral Feedings  
Given by 30-60 
minute bolus q 3 hours 
NG/OG  
Intervention Group  
Feeding 
Day  
Glucose  
mg/kg/min  
Protein,  
g/kg  
 
Lipids,  
g/kg  
IVF, 
mL/kg  
Enteral 
Feedings,  
mL/kg  
Feeding Type  Notes  
Day 1  6-10  
3.5-4  
3  
80-130  20  
Human Milk   
+HP HMF  
Add Enfamil High Protein Human 
Milk Fortifier to 22 calories  
Day 2  6-10  
4  
3  
80-130  20  
Human Milk  
+HP HMF  
 
Day 3  6-10  
4  
3  
90-110  40  
Human Milk  
+HP HMF  
 
Day 4  6-10  
4  
3  
90-110  40  
Human Milk  
+HP HMF  
 
Day 5  6-10  
4  
3  
70-90  60  
Human Milk  
+HP HMF  
 
Day 6  6-10  
3-4  
3  
70-90  60  
Human Milk  
+HP HMF  
 
Day 7  6-10  
2.5-4  
2  
50-70  80  
Human Milk  
+HP HMF  
 
Day 8  6-10  
2-3.5  
2  
50-70  80  
Human 
Milk +HP 
HMF  
 
Day 9  6-10  
1-2  
1-2  
30-50  100  
Human Milk 
+HP HMF  
 

 
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Day 10  6-10  
1   
1  
30-50  100  
Human Milk 
+HP HMF  
Increase Human Milk Fortifier to 
24 calories  
Day 11  6-10  
0-1  
0-1  
10-30  120  
Human Milk 
+HP HMF   
Add Supplements:  
NaCL or Bicitra 1.3 mEq/kg/day  
 
Day 12  0  
0  
0  
0  
140  
Human Milk 
+HP HMF   
Add Supplements:  
MgCO3 6 mg/kg/day  
Zinc 1 mg/kg/day  
Day 13  0  
0  
0  
0  
150  
Human Milk 
+HP HMF   
Add 6 mg/kg/day Ferinsol  
Day 14  0  
0  
0  
0  
150  
Human Milk 
+HP HMF   
Add 800 IU/day of Vitamin D  
[400 IU given BID]  
 
 
Control Group 
 
Parenteral Nutrition/IV Fluids  
 
Enteral Feedings  
Given by 30-60 
minute bolus q 3 hours 
NG/OG  
Control Group  
Feeding 
Day  
Glucose  
mg/kg/min  
Protein,  
g/kg  
 
Lipids,  
g/kg  
IVF, 
mL/kg  
Enteral 
Feedings,  
mL/kg  
Feeding 
Type  
Notes  
Day 1  6-10  
3.5-4  
3  
80-130  
20  
Human Milk    
Day 2  6-10  
4  
3  
80-130  
20  
Human Milk   
Day 3  6-10  
4  
3  
90-110  
40  
Human Milk   
Day 4  6-10  
4  
3  
90-110  
40  
Human Milk   
Day 5  6-10  
4  
3  
70-90  
60  
Human Milk   
Day 6  6-10  
3-4  
3  
70-90  
60  
Human Milk   
Day 7  6-10  
2.5-4  
2  
50-70  
80  
Human Milk   
Day 8  6-10  
2-3.5  
2  
50-70  
80  
Human 
Milk + HP 
HMF  
Add Enfamil High Protein 
Human Milk Fortifier to 
22 calories  
Day 9  6-10  
1-2  
1-2  
30-50  
100  
Human Milk 
+HP HMF  
 
Day 10  6-10  
1   
1  
30-50  
100  
Human Milk 
+HP HMF  
Increase Liquid Human Milk 
Fortifier to 24 calories  
Day 11  6-10  
0-1  
0-1  
10-30  
120  
Human Milk 
+HP HMF   
Add Supplements:  
NaCL or Bicitra 1.3 mEq/kg/day 
Day 12  0  
0  
0  
0  
140  
Human Milk 
+HP HMF   
Add Supplements:  
MgCO3 6 mg/kg/day  
Zinc 1 mg/kg/day  
Day 13  0  
0  
0  
0  
150  
Human Milk 
+HP HMF   
Add 6 mg/kg/day Ferinsol  

 
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Day 14  0  
0  
0  
0  
150  
Human Milk 
+HP HMF   
Add 800 IU/day of Vitamin D  
[400 IU given BID]  
 
 
Nutrient Supplementation 
In addition to HMF, other nutrients will be supplemented per the standard NICU feeding protocol. 
Supplementation of these nutrients will be provided to both study and non-study participants on the 
same feeding day.  
1. Vitamin D: Routine supplementation of Vitamin D will be given as 600 IU of Vitamin D (300 
IU BID) per feeding protocol. Additional Vitamin D may be added based on serum results of 1, 
25-Dihydroxy Vitamin D level per standard NICU procedures.  
2. Iron: Routine supplementation of iron will be given per feeding protocol as 6 mg/kg/day (3 
mg/kg/day BID).  
 
1. Data Types and Source Records: 
          Briefly describe the actual source records or measures that will be used to collect data about                    
participants. (All surveys, interview scripts, and data collection forms will be attached elsewhere in the application. 
Do not add other documents to the protocol.)  Describe what data will be collected and how it will be collected at all 
measurement/data collection time-points. 
 
Data will be collected from the patient’s EMR. Data to be collected include: date of birth, gender, 
estimated gestation age (EGA), Apgar score at 1 and 5 minutes, weights, head circumference, length, z-
scores for weight, length, and head circumference, total volume of feeds and TPN, number of missed 
enteral feeds, maternal milk vs donor milk volumes. Laboratory data including basic metabolic panel, 
magnesium, phosphorus, alkaline phosphatase and urine sodium, potassium and magnesium will be 
collected on day 22 as per the current standard of care. No blood collections or other procedures will be 
performed specifically for the study. Clinical outcomes will be collected to include: incidence of metabolic 
acidosis, NEC, oxygen requirement at 36 weeks, PDA, and death.  
 
Anthropometrics 
Anthropometrics are measured as part of the standard physical assessment of the preterm infant. For this 
study, all anthropometric measurements and calculations will follow AU’s standard preterm infant physical 
assessment guidelines.  
 
Weight 
1. Body weight will be measured within 24 hours of birth and then every 7 days until 28 days of life 
and again at 36 weeks post-menstrual age (PMA).   
2. Measurement of weight will be performed by the principal investigator (PI) and/or co-Investigators  
3. Weight will be measured (x 2) on a tared infant scale calibrated to the nearest 10 grams. Weights 
will be recorded in grams (g). Discrepancies of greater than 20g will be repeated. 
4. Infants will be weighed without a diaper.  
5. Average weight will be recorded in the EMR and documented in the database. 
6. Weight will be plotted on a gender-specific Fenton growth chart in the EMR and the percentile 
recorded in the database 
 
Weight Gain 

 
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1. Weight gain and growth velocity (GV) will be calculated at 28 days of life and 36 weeks PMA.  
2. Weight gain will be recorded as g/day  
3. GV will be calculated as follows and recorded in the database: 
GV (g/kg/day) =    
 
W= weight in grams 
D = day 
1 = interval of time chosen 
n= the end of the interval of time chosen 
 
Head Circumference 
1. Head circumference will be measured within 24 hours of birth (x 3) and then every 7 days until 28 
days of life and again at 36 weeks PMA. Discrepancies of greater than 0.5cm will be repeated. 
2. Measurement of head circumference will be performed by the principal investigator (PI) and/or co-
Investigators 
3. Head circumference will be measured with a Seca® non-stretch, Teflon® measuring tape. 
4. The tape will be applied firmly around the head above the supraorbital ridges, covering the most 
prominent part of the frontal bulge anteriorly, and over the part of the occiput that gives the 
maximum circumference. 
5. The greatest of three measurements will be recorded in centimeters (cm) and average recorded.  
6. Measurements will be recorded in the EMR and documented in the database. 
 
Length 
1. Body length will be measured within 24 hours of birth (x 2) and then every 7 days until 28 days of 
life and again at 36 weeks PMA.  
2. Length will be measured on a length board with a stationary head piece and adjustable foot piece. 
7. Measurement of length will be performed by the principal investigator (PI) and/or co-Investigators 
3. One examiner will hold the infant’s head with the Frankfurt plane in the vertical position and apply 
gentle traction to bring the top of the head into contact with the fixed headboard. The second 
examiner will hold the infant’s feet, toes pointing directly upward, and also applying gentle traction 
to bring the movable footboard to rest firmly against the infant’s heels.  
4. The average of two measurements, agreeing within 0.4 cm, will be recorded. 
5. Measurements will be recorded in the EMR and documented in the database. 
 
Z-scores 
1. Z-scores for weight, length, and head circumference will be retrieved from the EMR. Z-scores will 
be calculated at 28 days of life and 36 weeks PMA.  
2. Z-scores are calculated by Cerner® (Cerner®, North Kansas City, MO) and recorded on the Fenton 
growth curve in the EMR 
 
Mother’s Milk Collection 
1. Mother’s milk collection will follow standard NICU milk collection procedures: All study 
participants will be provided with: 
a. Instructions for milk collection, written and verbal 
b. Access to a hospital grade electric breast pump, individual pump kit, and a comfortable 
place to express  

 
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c. A manual breast pump will be provided upon request 
d. Sterile, single-use breastmilk collection containers 
e. Milk collection labels with a unique bar-code generated by the Cerner Bridge® bar-code 
system 
2. All breastmilk will be processed and prepared in the NICU Milk Lab by trained technicians per 
standard policy and procedure. 
3. The Cerner® Bridge label on each container of breastmilk will be scanned and recorded into the 
Cerner® Bridge breastmilk management system.  
4. All containers of mother’s milk collected in one 24 hour span of time will be pooled into a single 
container per standard NICU Milk Lab procedure. Expiration date and times will be adjusted by 
Cerner® Bridge once each container is scanned and combined.  
 
2. Describe the procedures performed to lessen the probability or magnitude of risks: 
As the only intervention that deviates from current standard of care is the use of HMF from feeding 
day 1 to feeding day 7, we do not anticipate any unique risks for study participants in either group. 
All SOPs for the handling of human milk and bedside feeding will be followed. 
3. Describe the duration of an individual subject’s participation in the study and the time 
involved also include the overall duration of the project: 
Neonates will be enrolled in the study from birth until 36 weeks post-menstrual age or 
discharge from the NICU, whichever comes first. Estimated time in the study is two to 
twelve weeks depending on gestational age at birth. 
 

 
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9. Data and Specimen Management 
 
a. Describe the data analysis plan, including any statistical procedures: 
All statistical analysis will be performed using SAS 9.4 and statistical significance 
will be assessed using an alpha level of 0.05.  Descriptive statistics within 
fortification group (day 1 or day 8) will be determined including means and 
standard deviations for continuous variables, frequencies and percentages for 
categorical variables, and medians and interquartile ranges for ordinal variables.  
Distributional assumptions will be examined before testing and if violations to the 
assumptions occur a transformation or nonparametric methods will be used.  
Missing data will not be imputed. 
 
To examine differences between the two groups and assess for potential 
confounding variables two-sample t-tests will be used for continuous variables, chi-
square tests will be used for categorical variables, and Wilcoxon Rank Sum tests 
will be used for ordinal data.  Variables that will be examined include all collected 
EMR data (e.g., demographics, feeding related, laboratory, and clinical measures) 
and anthropometric measures. 
 
To examine differences between the two groups (day 1 vs. day 8), a simple two-
sided two-sample t-test will be used as a preliminary test for differences in 
continuous outcomes (e.g., weight growth velocity, head circumference growth 
velocity,  length growth velocity, zscores).  Then, to control for various potential 
confounders or covariates, analysis of covariance (ANCOVA) will be used with the 
main effect of interest being the group effect.  Covariates that will be adjusted for 
include gestational age, total number of feed interruptions, incidence of metabolic 
acidosis, and NEC.  Because there are only two groups, no adjustment to the overall 
alpha level will be needed to control for multiple comparisons. 
 
☐  N/A       
 
b. When applicable, provide a power analysis: 
The sample size was determined assuming an alpha level of 0.05, power of 80%, a 
common standard deviation of 3.64, and a two-sided two-sample t-test to examine 
differences in weight growth velocity at 28days between the two feeding protocol 
groups.  The mean for the standard of care group (fortification beginning on day 8) 
was 10.6% and for the intervention group (fortification beginning on day 1) was 
12.3, 12.6 and 13.6.  The sample size required for each mean difference is below 
 
Assumed Mean in Each Group 
0. Sample Size 
per Group 
Fortification Day 8 
Fortification Day 1 
10.56 
12.25 
74 
10.56 
12.56 
53 
10.56 
13.56 
25 
A sample size of 25 per group, for a total of 50 subjects will be needed. 
☐  N/A       
 
 

 
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c. Describe how data and specimens will be handled: 
 
                Data will be collected and recorded on a coded spreadsheet that is stored on a 
research specific Box drive assigned by AU IRB.  
☐  N/A       
 
 
i. 
What information will be included in that data or associated with the specimens? 
The patient’s date of birth, estimated gestational age, race, gender, weight, head 
circumference, length, biochemical results for a basic metabolic panel, phosphorus, 
Vitamin D, magnesium, APGAR score, Ballard score, Urine results for sodium, 
potassium, chloride, and magnesium, intake to include parenteral nutrition, enteral 
nutrition, medications, and supplements. 
ii. 
Where and how data and/or specimens will be stored? 
Code list will be stored on the Human research drive separate from the data maintained 
by AU IRB.  
iii. 
How long will the data and/or specimens be stored? 
Data will be stored for 2 years following completion of this study.  
iv. 
Who will have access to the data or specimens? 
Only the PI and co-investigators will have access to the data.  
v. 
Who is responsible for receipt or transmission of the data and/or specimens? 
Data will not be transported.  
vi. 
How will data and/or specimens be transported? 
Data will not be transported.  
 
10. Provisions to Monitor the Data to Ensure the Safety of Subjects ☐ N/A 
 
The plan might include establishing a data monitoring committee and a plan for reporting data 
monitoring committee findings to the IRB and the sponsor. 
a. Describe the plan to periodically evaluate the data collected regarding both harms and 
benefits to determine whether subjects remain safe. 
Daily abdominal circumferences will be done by nursing staff in addition to monitoring for 
signs of feeding intolerance.  
b. Describe what data are reviewed, including safety data, untoward events, and efficacy data. 

 
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Abdominal circumferences will be measured daily. Monitoring for feeding intolerance will 
be ongoing.  
c. Describe how the safety information will be collected (e.g., with case report forms, at study 
visits, by telephone calls with participants). 
Bedside nursing staff documents abdominal circumferences in patient’s charts. Any signs of 
feeding intolerance is relayed to the primary care team.  
d. Describe the frequency of data collection, including when safety data collection starts. 
Abdominal circumferences are measured daily, starting at birth.  
e. Describe who will review the data. 
Information will be reviewed by the PI and sub-investigators.  
f. Describe the frequency or periodicity of review of cumulative data. 
Data will be reviewed weekly. 
g. Describe any conditions that trigger an immediate suspension of the research. 
Developmental of NEC, necrotizing enterocolitis. 
 
 
11. Withdrawal of Subjects                                                                     ☐ N/A       
a. If applicable, describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
 
Subjects will be withdrawn from the study should they meet any one of the following 
criteria: 
1. The subject’s parent (s) or legal guardian request that the subject be withdrawn 
from the study.  
2. If, in the attending neonatologist’s opinion, continuation in the study would be 
detrimental to the subject’s well being 
3. If the participant requires supplemental enteral intake from infant formula or 
additives such as carbohydrate, protein, or fat modulars, therefore altering the 
content of the fortified milk beyond the HP HMF.  
4. The subject is diagnosed with NEC stage IIb or higher as described by the Bell’s 
stages.  
5. The subject is diagnosed with a gastrointestinal perforation.  
6. After a subject has been discontinued, he/she will not be allowed to re-enroll in the 
study. The reason for a subject being discontinued will be documented in the 
database.  
☐  N/A       
b. If applicable, describe any procedures for orderly termination. 
 
☒  N/A       

 
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c. If applicable, describe procedures that will be followed when subjects 
withdraw from the research, including partial withdrawal from procedures 
with continued data collection. 
☒  N/A       
 
12. Risks to Subjects 
a. List the reasonably foreseeable risks.  
1. Physical risks: Minimal risk of feeding intolerance due to early fortification. Feeding intolerance 
may present as spit up, irritability, or abdominal distention. Possibility of increased risk of 
developing NEC, an intestinal infection. 
2. Psychological risk: no psychological risk 
3. Social risk: no social risk 
4. Legal risk: no legal risk 
5. Parents or legal guardians have no financial risks associated with this study.  
6. There will be no financial costs associated with inclusion in this study 
a. If applicable, describe any costs that subjects may be responsible for 
because of participation in the research. 
☒  N/A       
b. If applicable, describe risks to others who are not subjects. 
☒  N/A       
 
 
 

 
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13.  Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience from taking part in the research.  
Introducing higher caloric feeds at the onset of enteral feeds can improve growth outcomes for VLBW 
infants when compared to infants who begin fortification after the first week of life.  
 
14.  Confidentiality 
Describe the procedures for maintenance of confidentiality. 
1. Subjects are at risk of breach of confidentiality. All research team members have undergone 
confidentiality training (CITI, HIPAA, and PHI) and are aware of the consequences for breach of 
confidentiality.  
2. To protect subject privacy, data folders in use during testing will not contain personal identifiers 
and forms containing personal identifiers will be kept out of public view. 
3. All subjects will be given a unique identifier. 
4. Research raw data will be stored on a drive that is password protected, and databases will be stored 
on the AU IT provided human research drive. Only the PI and the co-investigators will have access 
to the drive. 
5. If an unanticipated research-related event arises, the PI will be immediately informed of the event. 
If the event requires medical attention, the study physicians will be contacted for decisions 
regarding further action as needed.  
6. Data folders in use during testing will not contain personal identifiers. Any study information about 
subjects will only be given out with the parent’s or legal guardian’s permissions. If the results of 
this study are published, the names of the subjects will not be used.  
7. Purging or destroying data will be done by shredding documents. PHI no longer needed will be 
deleted from databases. 
 
 
15. Incomplete Disclosure, Authorized Deception, or Deception                        ☒  N/A                       
 
 
 
 
 
 
 
 
 
 
 
16.  Consent Process 

 
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If you are obtaining consent of subjects describe the consenting process. Be sure to include the process to 
be used if enrolling illiterate, non-English speakers, individuals with impaired decision making capacity to 
consent, as applicable. 
1. Written consent will be obtained prior to performing any study related procedures with the 
exception of the collection of weight, length, and head circumference within the first 24 hours of 
life. Under some circumstances, mother (or guardian) may not be approached for study 
participation or be able to provide consent within the first 24 hours (e.g. maternal co-morbidity or 
in-patient at outlying hospital). As collection of these metrics are standard for each patient admitted 
to the NICU and do not represent additional risk to the potential participant, we may collect these 
measurements prior to consent. If consent is not obtained, measurements will be included in the 
EMR but will not be included in any study database. 
2. The subject’s mother (or guardian) will provide written consent and HIPAA authorization using the 
current version of the IRB-approved forms. Consent from the father will be obtained if required by 
the local IRB in accordance with IRB requirements.  
3. The PI (or co-I) will be responsible for obtaining informed consent and HIPAA authorization after 
the study has been explained and all questions answered. The original signed consent form will be 
filed in the subject’s record in accordance with institutional policy and a copy will be provided to 
the subject’s parents/legal guardian.  
4. If a protocol amendment requires revision to the informed consent form, the revised IRB approved 
form will be used to obtain and document re-consent from the subject’s parent/legal guardian for all 
subjects enrolled in the study.  
5. The language of the consent documents will be English. 
 
17.  Compensation for Research-Related Injury                      
This section is not required when research involves no more than Minimal Risk to subjects.☒ N/A 
 
18. Qualifications to Conduct Research and Resources Available                                                        
Describe the qualifications of you and your staff to conduct this research. The IRB is looking for 
information such as area(s) of expertise, past research experience, relevant certifications, etc. 
 
For international research or research with vulnerable populations, describe the qualifications (e.g., 
training, experience, oversight) of you and your staff as required to conduct the research. When applicable 
describe the knowledge of the local study sites, culture, and society. Provide enough information so the 
IRB knows that you have qualified staff for the proposed research. 
 
Note: If you specify a person by name, a change to that person will require prior approval by the IRB. If 
you specify people by role (e.g., coordinator, research assistant, Sub-Investigator, or pharmacist), a 
change to that person will not require prior approval by the IRB, provided that person meets the 
qualifications described above to fulfill their roles. 
 
The PI is a board certified pediatrician and current neonatal fellow with AU. The faculty advisor is a 
board-certified neonatologist.  

 
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a. Describe the availability of medical or psychological resources that subjects might need 
as a result of an anticipated consequences of the human research. 
1. Subjects will be provided with the PI’s contact information and encouraged to email with questions 
pertinent to enrollment in the study.  
2. All necessary medical resources that subjects might need as a result of anticipated consequences of 
the human research are available at Augusta University Medical Center. 
3. All study personnel are trained to fulfill their role in the specific study and have all training and 
credentials for participating in research studies at Augusta University Medical Center. 
 
b.   Describe your process to ensure that all persons assisting with the research are 
adequately informed about the protocol, the research procedures, and their duties and 
functions. 
The protocol and study documents will be reviewed at a study initiation meeting and all 
study personnel will be trained to perform study procedures (e.g. weight, length, and head 
circumference). Attendance will be recorded and kept with study records. Should 
amendments to the study be approved, personnel will be informed in writing and/or in 
person and additional training performed.