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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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