Body Weight Clinical Trial
Official title:
Serial Assessment of Body Fat Accrual in Very Preterm Infants: A Pilot Randomized Trial
Verified date | December 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
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
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) |
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