Effect of Protein Intake on Preterm Infant Body Composition

Effect of Protein Intake on Preterm Infant Body Composition

Sponsors

Lead sponsor: University of Oklahoma

Source 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.

Overall Status Completed
Start Date December 2014
Completion Date October 1, 2017
Primary Completion Date July 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Weight gain due to fat mass 4 weeks
Secondary Outcome
Measure Time Frame
Change in body weight 4 weeks
Change in percent fat mass 4 weeks
Change in length 4 weeks
Change in head circumference 4 weeks
Enrollment 36
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Protein supplementation

Description: 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.

Arm group label: Enhanced Protein Group

Intervention type: Dietary Supplement

Intervention name: Standard fortification

Description: Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.

Eligibility

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: 1 Year

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Courtney B Atchley, DO Principal Investigator OUHSC
Location
facility OUHSC Children's Hospital
Location Countries

United States

Verification Date

December 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Oklahoma

Investigator full name: Courtney B. Atchley, DO

Investigator title: Assistant Professor of Pediatrics

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Standard Protein Group

Arm group type: Active Comparator

Description: 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.

Arm group label: Enhanced Protein Group

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Investigator)

Source: ClinicalTrials.gov