Body Composition Reference Data for Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2020-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography and Multiple-frequency Bio-impedance Analysis

NCT00890344

Neonates

COMPLETED

Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

NCT00833222

Premature Birth

COMPLETED

Ultrasound Assessment of BC in the NICU

NCT03241082

Premature Infant

ACTIVE_NOT_RECRUITING

Body Composition at Discharge and Neurological Development at 2 Years in Very Preterm Infants (OPTIPREMA)

NCT02686801

Premature Birth of Newborn

UNKNOWN

Growth and Body Composition in Preterm Infants

NCT00875251

Body Composition

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Body Composition

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

24 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes