Effect of Increased Enteral Protein on Body Composition of Preterm Infants

Study Overview
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Brief Summary
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The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.

Detailed Description
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Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group). Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding. Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding. If parent agrees, stool dirty diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).

Official Title
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Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial

Conditions
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Premature Infant

Intervention / Treatment
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* Dietary Supplement: High protein supplementation
* Dietary Supplement: Standard protein supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 25 and 28 weeks of gestation Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14. Exclusion Criteria: Necrotizing enterocolitis (NEC) stage 2 or greater. Gastrointestinal or neurologic malformations. Terminal illness needing to limit or withhold support will be exclusion criteria.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 21 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein supplementation<br>Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. | Dietary Supplement: High protein supplementation<br>* To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive > 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.<br>|
| Active Comparator: Standard protein supplementation<br>Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. | Dietary Supplement: Standard protein supplementation<br>* Infants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant body composition | Percent body fat estimated by air displacement plethysmography | Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant body composition | Percent body fat estimated by air displacement plethysmography | Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) | 
| Growth | Weekly weight gain in grams | Birth to 3 months of corrected age | 
| Length | Weekly length in cm | Birth to 3 months of corrected age | 
| Head circumference | Weekly head circumference in cm | Birth to 3 months of corrected age | 
| Body mass index | Weight and height will be combined to report BMI in kg/m^2 | Birth to 3 months of corrected age | 
| Necrotizing enterocolitis | Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3 | Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first | 
| Death |  | Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein supplementation, Human milk fortification