Body Composition Reference Data for Preterm Infants

NCT02855814 | Completed

• 1 other identifier: 1001M76732
• Study Type: observational
• Target: 223
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (3)

• Fat mass

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

  Within 72 hours of birth

• Fat-free mass

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

  Within 72 hours of birth

• Percent body fat

  Percent body fat measured by air displacement plethysmography, in %

  Within 72 hours of birth

Interventions

Body Composition OTHER

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

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

AGA, singleton, healthy infants born between 30+0 and 36+6 weeks gestation were eligible. The study was conducted between 2010 and 2015 at three tertiary NICU's in the United States: the University of Minnesota Masonic Children's Hospital in Minneapolis, MN (referred to hereafter as the MN site), Santa Clara Valley Medical Center in San Jose, CA (referred to as the SC site), and Baystate Medical Center in Springfield, MA (referred to as BS).

You may qualify if:

• Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Santa Clara Valley Medical Center: collaborator
• Baystate Medical Center: collaborator

Related Publications (1)

• Demerath EW, Johnson W, Davern BA, Anderson CG, Shenberger JS, Misra S, Ramel SE. New body composition reference charts for preterm infants. Am J Clin Nutr. 2017 Jan;105(1):70-77. doi: 10.3945/ajcn.116.138248. Epub 2016 Nov 2.

  PMID: 27806978 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Body Composition

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 4, 2016
• Study Start: June 1, 2010
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share