Effect of Protein Intake on Preterm Infant Body Composition

Not Applicable

Completed

• Conditions: Premature; Infant, Light-for-dates
• Interventions: Dietary Supplement: Protein supplementation; Dietary Supplement: Standard fortification

• Registration Number: NCT02353013
• Lead Sponsor: University of Oklahoma

Brief 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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-02
• Primary Completion: 2017-07
• Study Completion: 2017-10-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Protein Group	Protein supplementation	For infants in this group, the target protein-energy ratio (PER) will be \~4 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. In addition, liquid protein will be added to provide protein supplementation and increase the PER.
Enhanced Protein Group	Standard fortification	For infants in this group, the target protein-energy ratio (PER) will be \~4 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. In addition, liquid protein will be added to provide protein supplementation and increase the PER.
Standard Protein Group	Standard fortification	For infants in this group, the target protein-energy ratio (PER) will be \~3 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula.

Primary Outcome Measures

Name	Time	Method
Weight gain due to fat mass	4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in body weight	4 weeks
Change in percent fat mass	4 weeks
Change in length	4 weeks
Change in head circumference	4 weeks

Trial Locations

Locations (1)

OUHSC Children's Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States