Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants (PREMA)

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth

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.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 9 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature and full term infants admitted to the University of Utah Newborn Intensive Care Unit, Intermediate Nursery or Well Baby Nursery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Full Term Infants; Infants born between 37 4/7 weeks and 42 3/7 weeks gestation.
Preterm Infants; Infants born between 32 4/7 weeks and 35 3/7 weeks gestation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Growth trajectory	Weekly

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Laurie Moyer-Mileur, PhD, University of Utah; Principal Investigator: Kristine Jordan, MPH, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 2, 2009

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: premature birth
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 24087