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Protein for Premies

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773902
First Posted: January 23, 2013
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen
  Purpose

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.


Condition Intervention
Extreme Prematurity Dietary Supplement: High Dose Protein (Individualized) Dietary Supplement: High Dose Protein (Standardized) Dietary Supplement: Standard Protein Supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: High Versus Standard Dose Protein for Very Preterm Infants

Further study details as provided by Axel Franz, University Hospital Tuebingen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • Plasma amino acid profile [ Time Frame: at 2 and 4 weeks after start of intervention ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: July 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773902


Locations
Germany
University Children's Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Axel Franz, MD Universität Tübingen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Axel Franz, PD Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01773902     History of Changes
Other Study ID Numbers: PfP3.2
First Submitted: January 15, 2013
First Posted: January 23, 2013
Last Update Posted: May 11, 2016
Last Verified: May 2016