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

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00833222
First received: January 29, 2009
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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.


Condition
Premature Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Growth trajectory [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Saliva; Urine


Enrollment: 72
Study Start Date: January 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   31 Weeks to 42 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833222

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Laurie Moyer-Mileur, PhD University of Utah
Principal Investigator: Kristine Jordan, MPH, PhD University of Utah
  More Information

No publications provided

Responsible Party: Laurie Moyer-Mileur, University of Utah
ClinicalTrials.gov Identifier: NCT00833222     History of Changes
Other Study ID Numbers: 24087
Study First Received: January 29, 2009
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
premature birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014