Body Composition Reference Data for Preterm Infants

Preterm Birth Clinical Trial

Official title:

Body Composition Reference Data for Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855814
• Other study ID #: 1001M76732
• Status: Completed
• Start date: June 2010
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Body Composition
No intervention. This is an observational, normative study of body composition variation in preterm infants

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	Baystate Medical Center, Santa Clara Valley Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat mass	Total body fat mass measured by air displacement plethysmography, in kg	Within 72 hours of birth
Primary	Fat-free mass	Total body fat-free mass measured by air displacement plethysmography, in kg	Within 72 hours of birth
Primary	Percent body fat	Percent body fat measured by air displacement plethysmography, in %	Within 72 hours of birth