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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Body Composition
No intervention. This is an observational, normative study of body composition variation in preterm infants

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Minnesota Baystate Medical Center, Santa Clara Valley Medical Center

Outcome

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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