Preterm Birth Clinical Trial
Official title:
Body Composition Reference Data for Preterm Infants
NCT number | NCT02855814 |
Other study ID # | 1001M76732 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | June 1, 2020 |
Verified date | March 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. However, there are no body composition reference curves available at this time for the preterm infant population. The purpose of this study is to collect cross-sectional body composition data using air displacement plethysmography (PEA POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants within 3 days of birth, for the purpose of generating means, standard deviations, and percentile values for total body fat mass, total fat free mass, and percent body fat for infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth retardation will be selected for form the reference sample. The goal is to generate a set of common reference curves to be used in clinical centers against which to compare body composition status for individual infants.
Status | Completed |
Enrollment | 223 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility | Inclusion Criteria: - Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age Exclusion Criteria: - Congenital defects that affect growth - Inability to tolerate room air for 5 minutes without desaturation or bradycardia - <1 kg birth weight - Parents did not provide consent |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | Baystate Medical Center, Santa Clara Valley Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fat mass | Total body fat mass measured by air displacement plethysmography, in kg | Within 72 hours of birth | |
Primary | Fat-free mass | Total body fat-free mass measured by air displacement plethysmography, in kg | Within 72 hours of birth | |
Primary | Percent body fat | Percent body fat measured by air displacement plethysmography, in % | Within 72 hours of birth |
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