Protein for Premies

Not Applicable

Completed

• Conditions: Extreme Prematurity
• Interventions: Dietary Supplement: Standard Protein Supplementation; Dietary Supplement: High Dose Protein (Individualized); Dietary Supplement: High Dose Protein (Standardized)

• Registration Number: NCT01773902
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Primary Completion: 2014-12
• Study Completion: 2016-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard protein supplementation	Standard Protein Supplementation	Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge
High Dose Protein (Individualized)	High Dose Protein (Individualized)	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
High Dose Protein (Standardized)	High Dose Protein (Standardized)	Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

University Children's Hospital Tuebingen; 🇩🇪 Tuebingen, Germany