Body Composition Reference Data for Preterm Infants

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 hour–72 hour

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body Composition

Other

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

Primary outcomes

Fat mass

Time frame: Within 72 hours of birth

Total body fat mass measured by air displacement plethysmography, in kg
Fat-free mass

Time frame: Within 72 hours of birth

Total body fat-free mass measured by air displacement plethysmography, in kg
Percent body fat

Time frame: Within 72 hours of birth

Percent body fat measured by air displacement plethysmography, in %

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

Baystate Medical Center
Santa Clara Valley Medical Center

Registry information

Important dates

Study start: 2010
Primary completion: 2020
Study completion: 2020
First posted: Aug 4, 2016
Registry last updated: Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed