Protein for Premies

University Hospital Tuebingen

Status: Completed

Conditions: Extreme Prematurity

Treatments: Dietary Supplement: Standard Protein Supplementation; Dietary Supplement: High Dose Protein (Individualized); Dietary Supplement: High Dose Protein (Standardized)

Study type: Interventional

Funder types: Other

Identifiers

NCT01773902

PfP3.2

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

High Dose Protein (Individualized)

Experimental group

Description:

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

Treatment:

Dietary Supplement: High Dose Protein (Individualized)

High Dose Protein (Standardized)

Experimental group

Description:

Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge

Treatment:

Dietary Supplement: High Dose Protein (Standardized)

Standard protein supplementation

Active Comparator group

Description:

Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge

Treatment:

Dietary Supplement: Standard Protein Supplementation