50 Participants Needed

Infant Body Composition Assessment for Premature Infants

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

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

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.12345

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.14678

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.2491011

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.

Research Team

AA

Ariel A. Salas, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 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 GroupActive Control1 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.

Find a Clinic Near You

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+

References

Infant body composition assessment in the neonatal intensive care unit (NICU) using air displacement plethysmography: Strategies for implementation into clinical workflow. [2021]
Evaluation of body composition in neonates and infants. [2008]
Nutritional assessment in preterm infants with special reference to body composition. [2008]
Measuring the body composition of preterm and term neonates: from research to clinical applications. [2009]
Nutritional assessment and measurement of body composition in preterm infants. [2018]
Evaluation of a new pediatric air-displacement plethysmograph for body-composition assessment by means of chemical analysis of bovine tissue phantoms. [2019]
Change in body composition of premature infants from parenteral nutrition discontinuation to term equivalent age. [2021]
Infant body composition in the PEA POD® era: what have we learned and where do we go from here? [2014]
Methods for measuring body composition in newborns--a comparative analysis. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Can Basic Characteristics Estimate Body Composition in Early Infancy? [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Body composition assessment in the infant. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security