Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

Premature Birth Clinical Trial

— PREMA  

Official title:

Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833222
• Other study ID #: 24087
• Status: Completed
• Phase: N/A
• First received: January 29, 2009
• Last updated: December 21, 2017
• Start date: January 2008
• Est. completion date: June 2012

Study information

• Verified date: December 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth trajectory		Weekly