Infant Body Composition Assessment for Premature Infants

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Gastrointestinal, Neurologic malformations, Terminal illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if monitoring the body fat of premature infants can help maintain a lower body fat percentage by the age of three months. The study will compare two groups: one where doctors have access to the baby's body fat measurements and one where they do not. Infants born between 28 and 32 weeks without serious gastrointestinal or neurological issues may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to the understanding of infant health and development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this assessment of infant body composition is safe for premature infants?

Research has shown that checking an infant's body composition is safe and well-tolerated. This non-invasive check does not involve surgery or needles. The process typically uses simple tools like scales and measuring tapes to assess fat and muscle.

Current studies report no adverse events or side effects from these checks. They are already used to help understand and predict future health issues, such as obesity or heart problems, as infants grow. This indicates that the process has been studied and found safe in similar situations.

For those considering a trial that includes body composition checks for infants, the evidence suggests it is a safe process for your little one. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how tracking infant body composition can improve care for premature infants. Unlike standard practices, which may not include detailed body composition data, this approach provides clinicians with precise information about an infant's growth and nutritional status. This could lead to more tailored and effective care decisions, potentially improving health outcomes for these vulnerable infants.

What evidence suggests that this assessment is effective for reducing body fat in premature infants?

Research shows that understanding an infant's body makeup is important for predicting future health. Studies suggest that a baby's body composition can indicate their risk of obesity and other health issues, like heart and metabolic problems, as they grow. In this trial, clinicians will monitor the body composition of infants in the intervention group, and this information will be available to them. Monitoring the amount of fat and non-fat mass in premature babies can better support their health and development. Many studies have also found that more non-fat mass links to better thinking and movement skills in newborns. This approach aims to improve health from an early age. ^{1 2 3 6 7}

Who Is on the Research Team?

Ariel A. Salas, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for very preterm infants born between 28 and 32 weeks of gestation. It's not suitable for those with terminal illnesses where support is limited or withheld, or babies with gastrointestinal or neurologic malformations.

Inclusion Criteria

Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria

I have issues with my digestive system or nervous system.

You have a serious, life-threatening illness and need special care or may not receive certain treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Infants undergo serial measurements of body composition during hospitalization, with data available to clinicians for the intervention group

Birth to hospital discharge

Control

Infants undergo serial measurements of body composition during hospitalization, but data is not available to clinicians for the control group

Birth to hospital discharge

Follow-up

Participants are monitored for changes in metabolic pathways, body composition, and growth metrics

Birth to 3 months of corrected age

What Are the Treatments Tested in This Trial?

Interventions

• Assessment of infant body composition

Trial Overview The study focuses on assessing body composition in these infants to see if early identification of changes in fat mass can reduce the percentage of body fat at the age of 3 months.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Infants randomly assigned to the intervention group will undergo serial measurements of infant body composition during their hospitalization. This information about infant body composition will be known to the clinicians caring for them (including reference data).

Group II: Control Group Active Control 1 Intervention

Infants randomly assigned to the control group will also undergo serial measurements of infant body composition during their hospitalization, but this information will not be available to the clinicians caring for them.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10513728/

Infant Body Composition: A Comprehensive Overview of ... Longitudinal studies suggest that body composition in infancy predicts later body composition, obesity, and other cardiometabolic outcomes in childhood.

2. mdpi.com mdpi.com/2227-9067/12/1/53

Body Composition in Preterm Infants: Current Insights and ... This comprehensive approach is designed to optimize health outcomes for preterm newborns by focusing on their body composition from an early stage.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744165X25000307

Short- and longer-term growth and development of fat ... Preterm infants typically experience faster growth rates than term-born infants, often doubling their weight in six to eight weeks.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37721459/

Infant body composition: A comprehensive overview ... Longitudinal studies suggest that body composition in infancy predicts later body composition, obesity, and other cardiometabolic outcomes in childhood.

5. karger.com karger.com/neo/article/120/6/681/862015/Trends-in-Preterm-Body-Composition-and

Trends in Preterm Body Composition and ... Many studies have associated body composition, specifically fat-free mass (FFM), with improved neonatal cognitive and motor outcomes [3, 4].

6. nature.com nature.com/articles/s41430-023-01394-5

Body composition assessment in 6-month-old infants Body composition assessment in 6-month-old infants: A comparison of two- and three-compartment models using data from the Baby-bod study.

7. withpower.com withpower.com/trial/phase-body-weight-8-2018-5a2e0

Infant Body Composition Assessment for Premature Infants Trial Overview The study focuses on assessing body composition in these infants to see if early identification of changes in fat mass can reduce the percentage ...