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Body Composition Reference Data for Preterm Infants

NCT02855814 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 223

Last updated 2022-03-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Body Composition

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

Sponsors & Collaborators

  • Santa Clara Valley Medical Center

    collaborator OTHER

  • Baystate Medical Center

    collaborator OTHER

  • University of Minnesota

    lead OTHER

Eligibility

Min Age
24 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2020-06-01
Completion
2020-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855814 on ClinicalTrials.gov