Protein for Premies

May 9, 2018 updated by: Axel Franz, University Hospital Tuebingen

High Versus Standard Dose Protein for Very Preterm Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University Children's Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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 (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: 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: 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: Standard protein supplementation
Protein supplementation independent of individual breast milk content using a standard dose of a standard 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)

Other Outcome Measures

Outcome Measure
Time Frame
Plasma amino acid profile
Time Frame: at 2 and 4 weeks after start of intervention
at 2 and 4 weeks after start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Axel Franz, MD, Universitat Tubingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (ESTIMATE)

January 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PfP3.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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