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Protein for Premies

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospital Tuebingen
Sponsor:
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01773902
First received: January 15, 2013
Last updated: December 20, 2013
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: High Versus Standard Dose Protein for Very Preterm Infants

Further study details as provided by 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Plasma amino acid profile [ Time Frame: at 2 and 4 weeks after start of intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773902

Contacts
Contact: Axel Franz, MD axel.franz@med.uni-tuebingen.de

Locations
Germany
University Children's Hospital Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Axel Franz, MD       axel.franz@med.uni-tuebingen.de   
Principal Investigator: Christoph Maas, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Axel Franz, MD University of Tuebingen, Germany
  More Information

No publications provided

Responsible Party: Axel Franz, PD Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01773902     History of Changes
Other Study ID Numbers: PfP3.2
Study First Received: January 15, 2013
Last Updated: December 20, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on November 25, 2014