Protein for Premies

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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