Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
Phase: NA
Conditions: Infant,Premature, Body Weight, Adiposity
Sponsor: University of Alabama at Birmingham

 
 
 
 
 
 
 
 
Serial Assessment of Body Fat Accrual in Very Preterm Infants 
 
 
Study Protocol 
 
 
Lead Study Investigator(s): 
Ariel A. Salas 
University of Alabama at Birmingham 
 
 
ClinicalTrials.gov number: 
NCT03575897 
 
 
Version date: 
March 14, 2018 

Page 14 
 
Prematurity 
Rapid
weight gain 
Excessive
body fat 
accrual 
Obesity
SPECIFIC AIMS 
With one of the highest rates of obesity1 and one of the highest 
rates of prematurity (approximately 30% higher than the national 
average)2, the state of Alabama suffers two problems of public 
health importance that disproportionately affect racial/ethnic 
minorities and increase health disparities in the United States. 
Obesity and prematurity are related [Figure 1]. Obesity is not only a 
risk factor for prematurity, but also an unanticipated consequence of 
prematurity in the increasing number of preterm infants that survive 
into adulthood. The use of high-calorie diets to improve 
neurodevelopment and prevent postnatal growth failure among 
preterm infants is associated with rapid weight gain and excessive 
body fat accrual. Metabolic reprogramming may play an important 
role in this long-lasting cycle. Although adults born at term and 
adults born preterm have a similar body mass index (BMI)3, adults 
born preterm have higher blood pressure, more insulin resistance4,5 
and higher body fat accrual4,5.  The higher body fat accrual found in 
 
Figure 1. Prematurity & obesity: 
a perpetual cycle 
 
 
adulthood has also been documented at term-equivalent age and during early infancy6, a critical period for 
infant development during which high-calorie diets are frequently used to promote rapid weight gain. 
Despite evidence that both rapid weight gain7 and excessive body fat accrual8 are associated with 
overweight and obesity, usual neonatal care for preterm infants does not include the assessment of body fat 
accrual. Similarly, screening programs to assess body composition in infants with a history of prematurity have 
not been established. By monitoring body fat accrual in preterm infants before and after hospital discharge, 
clinicians could modify dietary interventions in early infancy and prevent obesity and long-term related 
morbidities. In this pilot randomized trial, we will test the central hypothesis that very preterm infants (28 to 32 
weeks of gestation as defined by the World Health Organization) managed using information from monthly 
serial assessments of infant body composition from birth to hospital discharge will have lower percent body fat 
(%BF) at 3 months of age than infants managed using standard care (weight and other routine growth 
parameters). %BF at 3 months of age has a strong correlation with %BF at 4 years of age9. Our long-term goal 
is to develop a comprehensive nutritional program that incorporates assessment of body composition in the 
routine care of preterm infants and reduces variability in feeding practices before and after hospital discharge 
to minimize the risk of obesity mediated by rapid weight gain. 
Specific Aim 1: To test the hypothesis that provision of serial body fat accrual reports during 
hospitalization will enable personalized dietary interventions and reduce adiposity at 3 months of age 
in very preterm infants. We chose %BF at 3 months of age as the primary outcome of the trial because at this 
age: 1) body fat accrual can be measured with non-invasive methods10; 2) loss to follow-up rates are low9; 3) 
physical activity and other risk factors for obesity are less likely7; and 4) correlation with body fat accrual at 
preschool age is strong9. We selected very preterm infants as the ideal population to study the risk of obesity in 
preterm infants because they: 1) experience a high risk for adverse health outcomes3,5; 2) usually do not 
require supplemental oxygen after postnatal day 7; and 3) receive strictly controlled diets for more than 30 
days from birth to hospital discharge. With our improved understanding of the interaction between infant 
weight, body fat accrual, and dietary interventions, we plan to examine whether the provision of body fat 
accrual reports to clinicians and parents will impact infant weight gain and body fat accrual11. 
Specific Aim 2: To test the hypothesis that serial assessment of infant body composition 
attenuates health disparities in body fat accrual at 3 months of age by slowing weight gain following 
hospital discharge. The rationale for this aim is: 1) rapid weight gain during early infancy is highly prevalent 
among racial/ethnic minorities12,13; and 2) adjustment for rapid weight gain attenuates disparities in childhood 
obesity between racial/ethnic minorities and white infants7,12. We hypothesize that our intervention focused on 
personalized dietary interventions based on changes in infant body composition will reduce rapid weight gain 
and attenuate health disparities in body fat accrual. 
Obesity 
Prematurity 
Excessive 
body fat 
accrua 
Rapid 
weight gain 

Page 15 
 
RESEARCH STRATEGY 
SIGNIFICANCE 
Rapid weight gain increases the risk of metabolic reprogramming in preterm infants. For many 
years, the high prevalence of postnatal growth failure (weight below the 10th percentile for expected 
intrauterine growth) in the preterm population made weight the most important outcome of growth among 
preterm infants. Similarly, the association between rapid weight gain and improved neurodevelopment led 
clinicians to assume that slow weight gain was “inadequate growth” and that high-calorie diets to promote rapid 
weight gain were needed. 
Available clinical evidence no longer supports these assumptions. Current dietary interventions have not 
appreciably reduced postnatal growth failure. Postnatal growth failure remains prevalent and occurs in 
approximately 60%14-16 of the nearly 80,000 infants born preterm at 32 weeks of gestation or less every year in 
the United States2. Similarly, the benefits of rapid weight gain on neurodevelopment of preterm infants have 
not been consistently demonstrated. While 19 observational studies of low to moderate quality have associated 
rapid weight gain with improved neurodevelopmental outcomes17, 3 randomized trials of hospital-based 
nutritional interventions that reversed postnatal growth failure through rapid weight gain did not show benefits 
in neurodevelopment18-20. These inconsistencies between results from randomized trials and results from low 
to moderate quality observational studies suggest the presence of unmeasured confounding factors that affect 
both growth and cognition17 and demand caution with the assumption that promoting brain development 
through rapid weight gain outweighs the risk of potential long-term metabolic dysfunction. 
Rapid weight gain also known as catch-up growth could trigger changes in metabolic reprogramming. 
Results from interventional and observational studies indicate that high-calorie diets before and after hospital 
discharge to promote catch-up growth and prevent postnatal growth failure among preterm infants21 may result 
in hypertension, insulin resistance22, and disproportionate increase of body fat17,23, particularly when 
carbohydrates and fat are the primary source of energy. This clinical evidence of metabolic dysfunction 
resulting from rapid weight gain has been demonstrated in humans and animal models. Clinical studies 
consistently show that growth-restricted preterm infants are more likely to experience catch-up growth15,24 and 
corroborate conclusions from animal experiments that reveal an increased susceptibility to early metabolic 
reprogramming of adverse health outcomes in developing infants exposed to high-calorie diets17,25,26. In rats 
and mice with growth restriction as a result of poor maternal diet, rapid growth due to high-calorie diets 
increases susceptibility to obesity and reduces longevity27,28. The mechanisms of early metabolic 
reprogramming include permanent changes in organ structure due to suboptimal nutrition, epigenetic 
modifications that lead to changes in gene expression, and permanent effects on regulation of cellular aging25. 
Assessment of infant body composition offers important advantages over BMI as outcome of 
growth. BMI and infant body composition are outcomes of growth associated with long-term health. BMI is a 
widely accepted anthropometric index that is used to define obesity, but in early infancy, BMI has poor 
predictive accuracy for obesity and poor correlation with body fat accrual. In term infants, BMI only explains up 
to 43% of the variation in fat mass (FM)29,30. Furthermore, reduction of infant BMI to prevent obesity in 
adulthood is not currently recommended because high infant BMI values are associated with greater lean 
mass31. Body fat accrual during early infancy is a marker of fetal adaption and metabolic reprogramming that 
has a significant association with obesity and other adverse health outcomes32. Rapid weight gain is 
associated with higher risk of %BF, abnormal fat distribution, and overweight at school age8,33. 
Air-displacement plethysmography (PeaPod®, Life Measurement Instruments, Concord, CA) is one the 
less invasive and more accurate methods to assess infant body composition in early infancy32,34 Using air- 
displacement plethysmography, several studies have determined reference values of neonatal body fat accrual 
at different gestational ages6,10. At birth, body fat accrual expressed as %BF ranges from 6% at 30 weeks of 
gestation to 9.5% at 37 weeks of gestation.10 At term-equivalent age, all preterm infants have significantly 
higher %BF than infants born at term (up to 6% higher when measured by air-displacement 
plethysmography)29, irrespective of history of intrauterine growth restriction35. 

Page 16 
 
While studies that assessed infant body composition with either dual energy X-ray absorptiometry or 
bioelectrical impedance analysis suggest that fat free mass (FFM) can be predicted using weight data36, 
studies that assessed infant body composition with air-displacement plethysmography, a method with high 
accuracy and validity when compared to the gold standard carcass analysis32, suggest an unreliable 
correlation between anthropometric data and neonatal adiposity37 and body composition30 in preterm infants. 
Body fat accrual at 3 months of age predicts infant body composition at 4 years of age. Unlike body 
composition at term-equivalent age, body composition at 3 months of age has a strong correlation with body 
composition at 4 years of age in infants born preterm9. Large observational studies suggest that differences in 
body composition between term and preterm infants persist into adulthood4,5, but the implications of early 
alterations of growth and body composition are largely unknown despite evidence that early rapid weight gain 
and body fat accrual are determinants of later obesity risk in full-term and preterm infants5,38-40. Taken together, 
these data suggest that early changes in body composition following hospital discharge could be an important 
outcome of growth to analyze long-term health risks of rapid weight gain and body fat accrual during early 
development. Serial monitoring of body composition during infancy may allow nutritional support optimization 
that balances neurodevelopmental benefit and metabolic risk9. 
Slow weight gain after hospital discharge attenuates the risk of obesity among racial/ethnic 
minorities. Observational studies show that obesity and rapid weight gain in early infancy are more prevalent 
among blacks and Hispanics than among whites and that differences in feeding practices (breastfeeding rates, 
early introduction of complimentary foods and others) contribute to these disparities in infant weight gain and 
obesity12,13. Adjustment for these early risk factors related to infant feeding attenuates disparities in childhood 
obesity between minority and white infants7,12; therefore, it is plausible that, by providing more specific 
information about early changes in body composition instead of using an anthropometric index, clinicians and 
parents may alter their feeding regimens before and after hospital discharge in a manner that will reduce the 
risk for unhealthy gains in adiposity. Modifications of these early risk factors could have a substantial impact on 
preventing disparities in childhood obesity12. 
INNOVATION 
Despite clinicians’ ability to effectively control all external sources of nutrition in the immediate neonatal 
period, current dietary interventions and methods to assess postnatal growth have not led to significant 
improvement in growth and neurodevelopment. Comprehensive evaluation of postnatal growth with infant body 
composition is essential to guide appropriate and effective nutritional interventions for infants at high risk of 
obesity. 
The incorporation of a longitudinal assessment of infant body composition into current practices of 
neonatal care is innovative because it will provide a more sensitive index of the infant’s body habitus and 
thereby guide clinician decisions about dietary interventions. This change in practice could reduce the risk of 
overweight and obesity in very preterm infants. 
Serial assessment of infant body composition using air-displacement plethysmography, a validated 
method with reliable accuracy, to report body fat accrual in a randomized clinical trial is also one of the novel 
aspects of our proposal, as other research studies have used low-accuracy methods to estimate infant body 
composition6. 
APPROACH 
Our central hypothesis is that very preterm infants managed using information from serial assessments of 
infant body composition during their initial hospitalization will have lower percent body fat (%BF) at 3 months of 
age, irrespective of sex and race/ethnicity. 
Specific Aim 1 will test the hypothesis that, after establishing a program to monitor infant body 
composition before and after hospital discharge, identification of changes in body fat accrual will prompt 
individualized recommendations for dietary interventions that reduce %BF at 3 months of age in very preterm 
infants. 

Page 17 
 
Overview: Aim 1 will be a pilot randomized trial in which 50 very preterm infants will be randomly assigned 
in a 1:1 allocation ratio to either routine neonatal care (control group) or neonatal care with serial assessments 
of infant body composition (intervention group). The primary outcome will be %BF at 3 months of age [Table 1]. 
 
Table 1. Project timeline 
Critical steps 
Month 
Jun 
Jul 
Aug 
Sep 
Oct 
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
May 
Anticipated IRB approval 
(protocol & consent form) 
Patient screening and 
enrollment 
Body fat assessment at 3 
months of age 
Primary & secondary data 
analyses 
Results available for 
manuscript preparation 
 
Rationale: While weight, the key element of the operational definition of postnatal growth failure, remains 
useful to assess nutritional status, its limitations as the only method to assess nutritional status and health 
risks41 should not be ignored. The assumed benefit of catch-up growth on neurodevelopment should be 
weighed against the possibility that catch-up growth might cause harm and increase the risk of adult-onset 
metabolic disease24,26,42. Because infant weight gain predicts later obesity risk43, central adiposity44 and insulin 
resistance45, more research is needed to define the best strategies to provide adequate nutrition with a goal of 
preventing growth failure without increasing health risks of public health importance. The problem of increased 
adiposity soon after birth and into adulthood among preterm infants suggests that assessment of body fat 
accrual along with weight gain could be an effective strategy to achieve the goal of ideal growth while 
preventing unnecessary health risk. As defining the risk for abnormal cardiovascular and metabolic outcomes 
in this population has become critically important46, it is possible that early detection of atypical changes in 
infant body composition characterized by excessive body fat accrual could prompt changes in dietary 
interventions to reduce the risk of obesity, cardiovascular disease, and metabolic syndrome later in life. 
Study design 
Setting: The neonatal unit at UAB is one of the largest neonatal academic centers in the United States. 
We have admitted more than 200 very preterm infants over the past 2 years. This large numbers of very 
preterm infants admitted makes our unit the ideal environment to conduct comparative effectiveness trials. 
Participants: Very preterm infants with gestational ages between 28 and 32 weeks of gestation at the time 
of admission to our neonatal unit will be eligible for this trial. Gastrointestinal or neurologic malformations, and 
terminal illness requiring limited or withheld support will be exclusion criteria. 
Randomization, allocation concealment, and masking: After receiving approval by the Institutional Review 
Board (IRB) at UAB to conduct this trial, research nurses and investigators will obtain written parental consent 
before randomization. We will randomize study participants using computer generated random-block 
sequences and numbered, opaque, sealed envelopes that will be opened in sequential order. Twin infants will 
be randomized individually. The intervention will not be masked. 
Intervention: Infants randomly assigned to the intervention group will have the information about infant 
body composition known to the clinicians caring for them (including reference data). The use of this patient- 
specific information about nutritional status will assist clinicians to optimize nutrition using feeding guidelines 
that will be provided. Infants randomly assigned to the control group will also undergo serial measurements of 
body composition, but this information will not be available to the clinicians. 

Page 18 
 
A 
B 
Primary and secondary outcomes: The primary outcome will be %BF estimated by air displacement 
plethysmography at 3 months of age. Secondary outcomes will include %BF and fat-free mass (FFM) at 36 
weeks of postmenstrual age (PMA) or hospital discharge (whichever occurs first), postnatal growth restriction 
(below 10th percentile) at 36 weeks PMA or discharge, weight gain (g/kg/d) from birth to the end of the 
intervention, anthropometric measures at time of hospital discharge (weight, head circumference, and length), 
weight gain (g/kg/d) from hospital discharge to 3 months of age, anthropometric measures at 3 months of age 
(weight, head circumference, and length), and blood pressure values at 3 months of age. 
Assessment of infant body composition: Serial assessments of infant body composition with air 
displacement plethysmography in very preterm infants using the PeaPod® (Life Measurement Instruments, 
Concord, CA)32 will occur in the first 14 days after birth (baseline measure), at 32 weeks PMA, at 36 weeks 
PMA or hospital discharge (whichever occurs first), and at 3 months of age [Figure 2]. The PeaPod® and the 
neonatal unit are located in the same building. During hospitalization, nursery staff and parents, if present, will 
transport the infant to the exam room where the PeaPod® is located. In the exam room, nursery staff will 
undress the infant, place the snug cap, and transfer the infant to the PeaPod® when ready for weighing and 
scanning. The infant will wear only a cap on his/her head and will lie inside the scanner for approximately 2-3 
minutes to estimate total fat and fat-free mass according to body weight and volume47. The infant will breathe 
the normal air in the room and will be able to see and hear his/her parents. Equipment for respiratory support 
or monitoring will not be used during the assessment to avoid unnecessary recalibration of the PeaPod®. For 
assessment of body composition at 3 months of age, a follow-up visit will be scheduled prior to discharge from 
the hospital. The 3-month visit will also include a brief questionnaire about feeding practices at home and blood 
pressure measurements. The study coordinator will mail a reminder letter approximately 2 weeks prior to the 
date of the visit and will call the caregiver to remind them on the day prior to their scheduled appointment. 
Infants and a caregiver will return to the hospital to repeat the body composition assessment. A trained 
technician from the Nutrition Obesity Research Center (which owns and manages the PeaPod®) will operate it. 
 
Figure 2. Serial assessment of body fat accrual in very preterm infants* 
* Traditional growth chart report (A) and body fat accrual report (B) of a preterm infant born at 29 weeks of gestation and monitored from birth to 36 weeks PMA 
 
Control or monitoring of co-interventions: Clinical care and decisions about enteral nutrition will be 
conducted at the discretion of the attending physician. 

Page 19 
 
Study specimens. Because several experiments suggest that changes in gut microbiota can influence 
obesity48, we will obtain written informed consent from the parent(s) to collect 2 stool samples, 1 stool sample 
before hospital discharge and 1 stool sample at the 3-month follow-up visit for possible use in future studies. 
Similarly, consent from the parent(s) will be obtained to collect a serum sample and measure biomarkers of 
anabolism and growth prior to hospital discharge. 
Statistical Analysis Plan. This trial will record core data on nutrition as recommended by consensus 
groups49. For analysis of the primary outcome, an unadjusted T-test comparison of the mean %BF between 
control and intervention groups will be performed assuming a normal distribution of this variable50. In 
consideration of relevant biological variables, a pre-specified adjusted analysis for demographic and nutritional 
characteristics will be conducted to improve precision in treatment comparisons and remove variability 
associated with these covariates51,52. A similar approach will be used for secondary outcomes. Descriptive data 
will be expressed as the mean (SD) or number (percentage) of observations. The primary statistical analyses 
will be performed on an intention-to-treat basis49 with SAS software. 
Sample Size and Power Estimates. At our institution, the mean and SD of %BF in preterm infants at time 
of discharge is 15 and 3.6, respectively (unpublished data). Therefore, to detect a 3-point difference in %BF 
between groups with SD of 3.6, 0.05 level of significance, and 80% power for a T-test that compares means 
from two independent samples, a sample size of 46 patients will be necessary in this superiority trial. 
Anticipating that approximately 10% of study participants will be lost to follow-up for assessment of the primary 
outcome at 3 months of age, 2 patients will be added to each group and the sample size will be increased to 
50. We will include a total of 25 patients in each group (n=50). 
Potential Problems 
Enrollment rates: An average of 7 study participants per month were enrolled in a recently completed trial 
that assessed body composition of very preterm infants at our institution (unpublished data). To define a 
timeline for patient enrollment in this trial, we assumed that 50% of parents will refuse participation. 
Sample size: A negative outcome (i.e. %BF) was selected as the primary efficacy end point of this trial. We 
used our own institutional data to calculate the sample size for this trial and estimated that a 3% absolute 
difference was clinically meaningful because the average difference between term and preterm infants is 3%.6 
Follow-up: We estimated that follow-up rates at 3 months of age will be higher than our follow-up rates at 2 
years of age for extremely preterm infants (approximately 80% at our institution). Follow-up at 3 months of age 
to assess infant body composition will allow comparison of our results with reference data in term infants. 
Generalizability: Given the pilot nature of this trial, we will focus on minimizing systematic errors in the trial 
to improve accuracy of our results and increase internal validity. It is expected that the precision of our 
estimates and the external validity of our results will be affected by our small sample size. 
Specific Aim 2 will test the hypothesis that serial assessment of infant body composition slows weight 
gain following hospital discharge and attenuates health disparities in body fat accrual at 3 months of age. 
Overview and preliminary data: Aim 2 will be a secondary analysis of our pilot randomized trial. In a 
prospective study of body composition, we corroborated that racial/ethnic minorities have higher in-hospital 
growth rates than white infants (unpublished data). 
Inclusion criteria, exclusion criteria, and outcome: Demographic and nutritional data from infants who 
participated in the pilot trial will be used for this analysis. Infants with missing follow-up data will be excluded. 
%BF at 3 months of age will be the dependent variable in the primary analysis. 
Statistical analysis: In this analysis, race/ethnicity will be entered as a dichotomous variable: white 
(reference group) and black or Hispanic. To examine the association between weight gain at 2 different time 
points (before and after hospital discharge) and body fat accrual at 3 months of age within each racial/ethnic 
group, we will use multivariable regression models. Subsequently, to quantify the degree to which weight gain 
explains racial/ethnic disparities in body fat accrual, we will employ a decomposition analysis which will help us 
determine if changes in weight gain after serial monitoring of body fat accrual reduces differences (i.e. 
observed and predicted) in body fat accrual between minority and white infants7. 

Page 20 
 
HUMAN SUBJECTS 
RISKS TO HUMAN SUBJECTS 
Human Subjects’ Involvement, Characteristics, and Design. This is non-exempt human subjects 
research. 
Characteristics of participants: Our study population will reflect the epidemiology of prematurity in the state 
of Alabama, with approximately 56% being Black (African-American), 41% White (Non-Hispanic Caucasian), 
and the remaining 4% Hispanic/Other. This study population has been selected based on the frequency of 
nutritional problems observed at these gestational ages and the increased risk of adverse health outcomes in 
this vulnerable population. 
Sampling plan, recruitment, and retention. Patients admitted to the neonatal unit of UAB from June 2018 
to January 2019 will be screened to determine eligibility for the study. Because the protocol is designed to 
establish a new hospital-based practice early in life, mothers will be approached by the research staff before 
eligible very preterm infants reach full enteral feeding. 
Sources of Materials 
For study participants, data will be collected from electronic medical records. Data containing identifying 
information will be available only to the PI (Dr. Ariel A. Salas) and research personnel directly involved with this 
study. Information about the study will be shared without individual identifiers. Data will be collected from 
medical records in accordance with the study protocol. This will include demographic data and other 
nutrition/feeding data. 
Potential Risks 
Potential risks: The probability of risk for higher %BF in a patient that participates in this trial is not different 
than the probability of higher %BF in a patient that does not participate in the trial53. Other theoretical risks of 
this study are related to clinical decompensation during assessment of infant body composition. They include 
increased risk of bradycardia or desaturations. Previous studies, including ours (unpublished data), have not 
reported an association between assessment of infant body composition and any of the above-mentioned 
risks. Infants may experience some transient discomfort during the PeaPod® assessment which requires them 
to wear a tight-fitting cap but no other clothing or blanket. Therefore, there are no known risks associated with 
this trial except loss of confidentiality, as it involves data collection. 
Breach of confidentiality: The main potential risk of this study is breach of confidentiality. This is one of the 
most common risks of participation in clinical research. Accordingly, our team has designed a strategy to 
protect participant confidentiality. All participants will be informed of study procedures and gauged for 
understanding of study tasks. In addition, study personnel will follow regulatory guidelines for obtaining 
informed consent. 
Alternative treatments and procedures: Participants in the intervention and control groups will have full 
access to all available standard of care clinical services at our neonatal unit, and parents are permitted to 
withdraw or refuse participation at any time. 
Adequacy of Protection against Risks 
Recruitment and Informed Consent 
Recruitment: When a potential participant is identified, a member of the study will see the parents and/or 
mother in her room or the baby’s room and explain the study. The risks and benefits will be discussed with the 
parents and time will be given to them to ask questions. It will be made known to them that no treatment will be 
withheld from their child if they participate in the study. 
Informed consent: The research team will attempt to obtain written consent after giving the parents a 
minimum of 24 hours to think about the study information and ask questions. Randomization will define study 
group assignment 
Study Monitoring Plan. This protocol will be reviewed by the IRB at UAB. Serious adverse events 
including severe clinical deterioration after assessment of infant body composition will be reported to the 
principal investigator. Moderate to major complications, defined for the purpose of this trial as events requiring 
immediate medical attention and/or interventions due to worsening clinical status, will also trigger a notification 
to the principal investigator. In previous studies that assessed infant body composition in stable preterm 

Page 21 
 
infants, including ours (unpublished data), serious adverse events including bradycardia, desaturations, 
hypothermia, sepsis, or death were not reported. No interim analyses are planned. 
Protections against Risk. Our team will make every effort to protect all participants’ confidential and 
private information in order to minimize possible study-associated risks. All findings related to any research will 
be available and provided to study participants in accordance with standard practices. We will also inform all 
participants that their participation is voluntary, and we will utilize study identification codes in place of personal 
identifiers on study materials. We will also employ storage and encryption techniques in compliance with UAB 
Data Security standards to safeguard all electronic data, as well as protections outlined in Subpart C of title 45, 
part 4 Code of Federal Regulations. All study personnel are required to renew Human Subjects training 
biannually. No data will be accepted from or distributed to the principal investigator or study staff if regulatory 
training is not current. 
Any provider or caregiver involved in the trial will be able to write to the study coordinator to draw attention 
to any concern they may have about the possibility of harm arising from the intervention under investigation. 
Potential Benefits of the Proposed Research to Human Subjects and Others 
Potential benefits of this study are to provide stronger evidence for the safety and efficacy of monitoring 
body fat accrual as a way of optimizing caloric intake, growth, and fat-free mass in preterm infants. Better 
quantitative and qualitative outcomes of growth may also be associated with improved long-term 
neurodevelopmental outcomes. 
The potential benefits of this research may include reduction of postnatal growth restriction, reduction in 
infant morbidity mediated through improved neonatal nutrition, and better growth at time of discharge. 
Reductions of postnatal growth restriction and improved nutritional parameters could improve long-term 
neurodevelopmental outcomes of infants. There will be benefit to the medical community in providing additional 
information on infant body composition in preterm infants. 
Importance of the Knowledge to be Gained 
As the risk to individual participants is small and potential benefits are significant, the risk/benefit ratio is 
favorable. 
ClinicalTrials.gov Requirements 
A description of this randomized trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
law. This website will not include information that can identify participants. The submission for review and 
approval of the proposed research by an IRB will be initiated after peer review of the research protocol. 
Certification of IRB approval will be sent to the Office of Sponsored Programs. Education in the protection of 
human research participants will be required for all research team members involved in this trial. Our data 
sharing plan will protect the rights and confidentiality of participants. 
Inclusion of Children and Minorities 
Inclusion of Minorities. Selection of participants for inclusion in the study will be completely independent 
of ethnicity or race. 
Inclusion of Children. Children have been selected as the study population based on the frequency of 
nutritional problems observed at these gestational ages and the increased risk of postnatal growth restriction in 
this vulnerable population. 

Page 22 
 
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