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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual. The study hypothesis is that identification of early changes in infant body composition (i.e. amount of fat mass and fat-free mass) reduces % body fat at 3 months of age.

Will I have to stop taking my current medications?

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

Is the assessment of infant body composition safe for premature infants?

The assessment of infant body composition using methods like air displacement plethysmography (ADP) is considered noninvasive and suitable for use in preterm and term infants, indicating it is generally safe. ^{1 2 3 4 5}

How does the treatment for assessing infant body composition differ from other treatments for premature infants?

This treatment is unique because it focuses on non-invasive and accurate methods to assess body composition, which is crucial for understanding the nutritional needs and health programming of premature infants. Unlike other treatments that may focus on immediate medical interventions, this approach provides insights into long-term health outcomes by evaluating body fatness, bone mineralization, and lean tissue quality. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Assessment of infant body composition for premature infants?

Research shows that understanding and monitoring body composition in infants, especially in the NICU, can improve nutritional management and clinical outcomes. Techniques like air displacement plethysmography (ADP) help assess fat and fat-free mass, which are crucial for evaluating growth and nutritional needs in preterm infants. ^{2 4 9 10 11}

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. England pubmed.ncbi.nlm.nih.gov

Infant body composition assessment in the neonatal intensive care unit (NICU) using air displacement plethysmography: Strategies for implementation into clinical workflow. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of body composition in neonates and infants. [2008]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Nutritional assessment in preterm infants with special reference to body composition. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Measuring the body composition of preterm and term neonates: from research to clinical applications. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Nutritional assessment and measurement of body composition in preterm infants. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a new pediatric air-displacement plethysmograph for body-composition assessment by means of chemical analysis of bovine tissue phantoms. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

Change in body composition of premature infants from parenteral nutrition discontinuation to term equivalent age. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Infant body composition in the PEA POD® era: what have we learned and where do we go from here? [2014]

9. Germany pubmed.ncbi.nlm.nih.gov

Methods for measuring body composition in newborns--a comparative analysis. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Can Basic Characteristics Estimate Body Composition in Early Infancy? [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Body composition assessment in the infant. [2021]