Protein for Premies

Study Overview
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Brief Summary
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Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established. This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.

Official Title
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High Versus Standard Dose Protein for Very Preterm Infants

Conditions
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Extreme Prematurity

Intervention / Treatment
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* Dietary Supplement: High Dose Protein (Individualized)
* Dietary Supplement: High Dose Protein (Standardized)
* Dietary Supplement: Standard Protein Supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: very preterm infants <32 weeks gestation and <1500g birth weight > 100ml/kg/d of enteral feeding Exclusion Criteria: missing informed consent decision not to feed breast milk congenital malformations age > 7 days at study entry

Ages Eligible for Study
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Maximum Age: 7 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Protein (Individualized)<br>Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge | Dietary Supplement: High Dose Protein (Individualized)<br>* Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge<br>|
| Experimental: High Dose Protein (Standardized)<br>Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge | Dietary Supplement: High Dose Protein (Standardized)<br>* Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge<br>|
| Active Comparator: Standard protein supplementation<br>Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge | Dietary Supplement: Standard Protein Supplementation<br>* Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head circumference growth |  | From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA) |