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Body Composition Reference Data for Preterm Infants

Body Composition Reference Data for Preterm Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02855814
Enrollment
223
Registered
2016-08-04
Start date
2010-06-30
Completion date
2020-06-01
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Brief 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.

Interventions

OTHERBody Composition

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

Sponsors

Santa Clara Valley Medical Center
CollaboratorOTHER
Baystate Medical Center
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
24 Hours to 72 Hours
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fat massWithin 72 hours of birthTotal body fat mass measured by air displacement plethysmography, in kg
Fat-free massWithin 72 hours of birthTotal body fat-free mass measured by air displacement plethysmography, in kg
Percent body fatWithin 72 hours of birthPercent body fat measured by air displacement plethysmography, in %

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026