Overview

This trial is active, not recruiting.

Condition extreme prematurity
Treatments high dose protein (individualized), high dose protein (standardized), standard protein supplementation
Sponsor University Hospital Tuebingen
Start date October 2012
End date December 2014
Trial size 60 participants
Trial identifier NCT01773902, PfP3.2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
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 (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
(Experimental)
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
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
(Active Comparator)
Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge
standard protein supplementation
Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge

Primary Outcomes

Measure
Weight gain
time frame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)

Secondary Outcomes

Measure
Head circumference growth
time frame: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)

Eligibility Criteria

Male or female participants up to 7 days old.

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

Additional Information

Official title High Versus Standard Dose Protein for Very Preterm Infants
Principal investigator Axel Franz, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.