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Completed

NCT Number: NCT00833222

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

31 week–42 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

  • 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.
  • 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.
  • To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements.
  • Compare growth, body composition and bone strength between infants born preterm to infants born full term.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Growth trajectory

    Time frame: Weekly

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Acronym: PREMA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2009
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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