Effect of Protein Intake on Preterm Infant Body Composition

Completed · Not applicable

Conditions studied: Premature; Infant, Light-for-dates

In brief

The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.

Key facts

Study ID

NCT02353013

Run by

University of Oklahoma

People needed

36

Starts

2014-12-01

Expected to finish

2017-10-01

Last updated by the study team

2017-12-22

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Premature infants born less than 32 weeks EGA
• Growth that is appropriate for gestational age (AGA)
• Admitted to OU Children's NICU, inborn or outborn
• Receiving enteral feedings <100 mL/kg/day
• Hemodynamically stable

You may not qualify if…

• Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
• Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
• Inborn errors of metabolism
• History of necrotizing enterocolitis Bell stage III
• Cerebrospinal fluid indwelling shunt (affects body composition measurements)
• Expected death prior to 36 weeks EGA (the end of the study period)
• Inability to meet Pea Pod® requirements for the first measurement
• On vasopressor medications

Where it is running

• OUHSC Children's Hospital — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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