Serial Assessment of Body Fat Accrual in Very Preterm Infants

Not Applicable

Active, not recruiting

• Conditions: Infant,Premature; Body Weight; Adiposity
• Interventions: Diagnostic Test: Assessment of infant body composition

• Registration Number: NCT03575897
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Infants in the intervention group will have the information about infant body composition known to the clinicians caring for them (including reference data). Infants in the control group will also undergo serial measurements of infant body composition, but this information will not be available to the clinicians.

If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).

Study Timeline

• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-03
• Study Start: 2018-09-10
• Primary Completion: 2020-01-16
• Results First Submitted: 2021-02-13
• Results First Submitted QC: 2021-04-25
• Results First Posted: 2021-05-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-27
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Gestational age between 28 and 32 weeks of gestation

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Exclusion Criteria

• Gastrointestinal or neurologic malformations
• Terminal illness requiring limited or withheld support

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Assessment of infant body composition	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).
Control Group	Assessment of infant body composition	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.

Primary Outcome Measures

Name	Time	Method
Infant Body Composition	Assessed at 3 months of corrected age	Percent body fat estimated by air displacement plethysmography

Secondary Outcome Measures

Name	Time	Method
Growth	Birth to 3 months of corrected age	Weekly weight gain in grams
Length	3 months of corrected age	Length in cm at 3 months of corrected age
Head Circumference	3 months of corrected age	Head circumference in cm at 3 months of corrected age
Body Mass Index	3 months of corrected age	Weight and height at 3 months of corrected age combined to report BMI in kg/m\^2
Infant Body Composition	Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)	Percent body fat estimated by air displacement plethysmography

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States