NCT02353013

Effect of Protein Intake on Preterm Infant Body Composition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 1 Minute – 1 Year
• Healthy volunteers: Not accepted

Summary

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

Detailed description

American Academy of Pediatrics guidelines define the growth rate of preterm, underweight babies as adequate if it matches the age-equivalent weight gains typical of term infants, approximately 10-15 grams per kg per day. Unfortunately, many pre-terms, especially very low birth weight ones, do not achieve this rate, resulting in neurodevelopmental deficits and low discharge weights. Typical feeding regimens, designed to increase weight gain, however, have been shown to increase the rate of fat accretion and increase the risk of obesity and metabolic disorders, such as insulin resistance and type 2 diabetes, later in life. Research has shown that higher protein diets can reduce the accretion of body fat in older, normal weight infants but this has not been systematically tested in low birth weight pre-terms. The current study will compare weight gain based on fat accretion and change in body composition in preterm infants receiving higher (4g/100 kcal) versus lower (3 g/100 kcal) protein-energy ratio diets. The hypothesis tested in this study is: Increased protein intake will reduce the percentage of weight gain due to fat accretion in pre-term infants. The identification of an effective feeding regimen that would both allow pre-term infants to acquire age-equivalent growth rates similar to those of term infants while avoiding the excess accretion of body fat could significantly improve the long term health outcomes of this high-risk population.

Conditions

• Premature; Infant, Light-for-dates

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protein supplementation	Standard fortification of human milk may not have enough protein for optimal growth of premature infants. The investigators will add extra protein to this group to increase the protein consumed.
DIETARY_SUPPLEMENT	Standard fortification	Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-07-01
• Completion: 2017-10-01
• First posted: 2015-02-02
• Last updated: 2017-12-22

Locations

1 site across 1 country: United States