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Completed

NCT Number: NCT01773902

Protein for Premies

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.

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Key information

Conditions

Extreme Prematurity

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Tuebingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Dose Protein (Individualized)

Dietary Supplement

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)

Dietary Supplement

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

Standard protein supplementation

Dietary Supplement

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

Primary outcomes

  1. 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

  1. 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)

Other outcomes

  1. Plasma amino acid profile

    Time frame: at 2 and 4 weeks after start of intervention

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

High Versus Standard Dose Protein for Very Preterm Infants

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jan 23, 2013
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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