Serial Assessment of Body Fat Accrual in Very Preterm Infants

Body Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03575897
• Other study ID #: 300001753
• Secondary ID: 2U54MD000502
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 14 Days

Eligibility

Inclusion Criteria:

• Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adiposity
• Body Weight
• Infant,Premature

Intervention

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)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salas AA, Jerome ML, Chandler-Laney P, Ambalavanan N, Carlo WA. Serial assessment of fat and fat-free mass accretion in very preterm infants: a randomized trial. Pediatr Res. 2020 Nov;88(5):733-738. doi: 10.1038/s41390-020-1052-x. Epub 2020 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Intestinal Microbiome	Determined by molecular analyses of bacteria in fecal samples	Birth to 3 months of corrected age
Other	Changes in Metabolic Pathways	Determined by molecular analyses of serum samples	Birth to 3 months of corrected age
Primary	Infant Body Composition	Percent body fat estimated by air displacement plethysmography	Assessed at 3 months of corrected age
Secondary	Growth	Weekly weight gain in grams	Birth to 3 months of corrected age
Secondary	Length	Length in cm at 3 months of corrected age	3 months of corrected age
Secondary	Head Circumference	Head circumference in cm at 3 months of corrected age	3 months of corrected age
Secondary	Body Mass Index	Weight and height at 3 months of corrected age combined to report BMI in kg/m^2	3 months of corrected age
Secondary	Infant Body Composition	Percent body fat estimated by air displacement plethysmography	Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)