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Infant Body Composition Assessment for Premature Infants

N/A

Waitlist Available

Led By Ariel A. Salas, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Gastrointestinal or neurologic malformations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months of corrected age

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether measuring an infant's body composition could help reduce obesity later on.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves assessment rather than medication, there are no direct side effects related to drugs. However, handling and measuring procedures may cause discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have issues with my digestive system or nervous system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months of corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months of corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months of corrected age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Body Mass Index

Growth

Head Circumference

+2 more

Other study objectives

Changes in Intestinal Microbiome

Changes in Metabolic Pathways

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 1Eligibility criteria met