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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
History of Changes

January 29, 2009
July 2, 2012
January 2008
June 2012   (final data collection date for primary outcome measure)
Growth trajectory [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833222 on ClinicalTrials.gov Archive Site
Not Provided
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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

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.
  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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Saliva; Urine
Non-Probability Sample

Premature and full term infants admitted to the University of Utah Newborn Intensive Care Unit, Intermediate Nursery or Well Baby Nursery
Premature Birth
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
31 Weeks to 42 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833222
24087
No
Laurie Moyer-Mileur, University of Utah
University of Utah
Not Provided
Principal Investigator: Laurie Moyer-Mileur, PhD University of Utah
Principal Investigator: Kristine Jordan, MPH, PhD University of Utah
University of Utah
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP