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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833222
First Posted: February 2, 2009
Last Update Posted: July 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Utah
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Laurie Moyer-Mileur, University of Utah
ClinicalTrials.gov Identifier: NCT00833222     History of Changes
Other Study ID Numbers: 24087
First Submitted: January 29, 2009
First Posted: February 2, 2009
Last Update Posted: July 3, 2012
Last Verified: July 2012

Keywords provided by University of Utah:
premature birth

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