NCT01773902

Protein for Premies

High Versus Standard Dose Protein for Very Preterm Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Extreme Prematurity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
DIETARY_SUPPLEMENT	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
DIETARY_SUPPLEMENT	Standard Protein Supplementation	Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-12-01
• Completion: 2016-07-01
• First posted: 2013-01-23
• Last updated: 2018-05-15

Locations

1 site across 1 country: Germany