This trial is active, not recruiting.

Condition preterm birth
Treatment body composition
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator Santa Clara Valley Medical Center
Start date June 2010
End date January 2015
Trial size 223 participants
Trial identifier NCT02855814, 1001M76732


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional

Primary Outcomes

Fat mass
time frame: Within 72 hours of birth
Fat-free mass
time frame: Within 72 hours of birth
Percent body fat
time frame: Within 72 hours of birth

Eligibility Criteria

Male or female participants up to 72 hours old.

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

Additional Information

Official title Body Composition Reference Data for Preterm Infants
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.