Effect of Protein Intake on Preterm Infant Body Composition

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Protein Intake on Preterm Infant Body Composition

Conditions
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Premature; Infant, Light-for-dates

Intervention / Treatment
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* Dietary Supplement: Protein supplementation
* Dietary Supplement: Standard fortification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Protein Group<br>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. | Dietary Supplement: Standard fortification<br>* Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.<br>|
| Experimental: Enhanced Protein Group<br>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. | Dietary Supplement: Protein supplementation<br>* 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.<br>Dietary Supplement: Standard fortification<br>* Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain due to fat mass |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein intake, body composition