NCT03575897

Serial Assessment of Body Fat Accrual in Very Preterm Infants

Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Not accepted

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).

Conditions

• Infant,Premature
• Body Weight
• Adiposity

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Assessment of infant body composition	Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)

Timeline

• Start date: 2018-09-10
• Primary completion: 2020-01-16
• Completion: 2026-12-01
• First posted: 2018-07-03
• Last updated: 2026-03-23
• Results posted: 2021-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study