Protein for Premies

Extreme Prematurity Clinical Trial

Official title:

High Versus Standard Dose Protein for Very Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773902
• Other study ID #: PfP3.2
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: July 2016

Study information

• Verified date: May 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Extreme Prematurity

Intervention

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

Locations

Country	Name	City	State
Germany	University Children's Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma amino acid profile		at 2 and 4 weeks after start of intervention
Primary	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	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)