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Protein for Premies

Primary Purpose

Extreme Prematurity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High Dose Protein (Individualized)
High Dose Protein (Standardized)
Standard Protein Supplementation
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Extreme Prematurity

Eligibility Criteria

undefined - 7 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • University Children's Hospital Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

High Dose Protein (Individualized)

High Dose Protein (Standardized)

Standard protein supplementation

Arm 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

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

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

Outcomes

Primary Outcome Measures

Weight gain

Secondary Outcome Measures

Head circumference growth

Full Information

First Posted
January 15, 2013
Last Updated
May 9, 2018
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT01773902
Brief Title
Protein for Premies
Official Title
High Versus Standard Dose Protein for Very Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extreme Prematurity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose Protein (Individualized)
Arm Type
Experimental
Arm 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
Arm Title
High Dose Protein (Standardized)
Arm Type
Experimental
Arm Description
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
Arm Title
Standard protein supplementation
Arm Type
Active Comparator
Arm Description
Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge
Intervention Type
Dietary Supplement
Intervention Name(s)
High Dose Protein (Individualized)
Intervention 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
Intervention Type
Dietary Supplement
Intervention Name(s)
High Dose Protein (Standardized)
Intervention Description
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Protein Supplementation
Intervention Description
Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Plasma amino acid profile
Time Frame
at 2 and 4 weeks after start of intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Franz, MD
Organizational Affiliation
Universität Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27893064
Citation
Maas C, Mathes M, Bleeker C, Vek J, Bernhard W, Wiechers C, Peter A, Poets CF, Franz AR. Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jan 1;171(1):16-22. doi: 10.1001/jamapediatrics.2016.2681.
Results Reference
result
PubMed Identifier
29739389
Citation
Mathes M, Maas C, Bleeker C, Vek J, Bernhard W, Peter A, Poets CF, Franz AR. Effect of increased enteral protein intake on plasma and urinary urea concentrations in preterm infants born at < 32 weeks gestation and < 1500 g birth weight enrolled in a randomized controlled trial - a secondary analysis. BMC Pediatr. 2018 May 8;18(1):154. doi: 10.1186/s12887-018-1136-5.
Results Reference
derived
PubMed Identifier
27164830
Citation
Maas C, Franz AR, Shunova A, Mathes M, Bleeker C, Poets CF, Schleicher E, Bernhard W. Choline and polyunsaturated fatty acids in preterm infants' maternal milk. Eur J Nutr. 2017 Jun;56(4):1733-1742. doi: 10.1007/s00394-016-1220-2. Epub 2016 May 10.
Results Reference
derived

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Protein for Premies

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