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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014