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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00833222
Acronym
PREMA
Enrollment
72
Registered
2009-02-02
Start date
2008-01-31
Completion date
2012-06-30
Last updated
2017-12-26

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

Conditions

Premature Birth

Keywords

premature birth

Brief summary

The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation \[32-35 weeks post-menstrual age (PMA)\] premature infants.

Detailed description

1. To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth. 2. To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin. 3. To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements. 4. Compare growth, body composition and bone strength between infants born preterm to infants born full term.

Interventions

None listed

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
31 Weeks to 42 Weeks
Healthy volunteers
Yes

Inclusion criteria

* Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth * Birth weight between the 5th and 95th percentile corrected for gestational age

Exclusion criteria

* Chromosomal abnormalities * Major congenital anomalies * Major surgery * Severe CNS injury * Inborn errors of metabolism * Assisted ventilation * Inability to start enteral feeds by 96 hours of age

Design outcomes

Primary

MeasureTime frame
Growth trajectoryWeekly

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026