NCT01773902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

January 15, 2013

Last Update Submit

May 9, 2018

Conditions

Extreme Prematurity

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    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

    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

    at 2 and 4 weeks after start of intervention

Study Arms (3)

High Dose Protein (Individualized)

EXPERIMENTAL

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)

High Dose Protein (Standardized)

EXPERIMENTAL

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)

Standard protein supplementation

ACTIVE COMPARATOR

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

Interventions

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 (Individualized)
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

High Dose Protein (Standardized)
Standard Protein SupplementationDIETARY_SUPPLEMENT

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

Standard protein supplementation

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • very preterm infants \<32 weeks gestation and \<1500g birth weight
  • \> 100ml/kg/d of enteral feeding

You may not qualify if:

  • missing informed consent
  • decision not to feed breast milk
  • congenital malformations
  • age \> 7 days at study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (3)

  • 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.

    PMID: 27893064RESULT

  • 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.

    PMID: 29739389DERIVED

  • 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.

    PMID: 27164830DERIVED

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • Axel Franz, MD

    Universität Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med.

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 23, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

July 1, 2016

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

DE(1)