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Dietary Protein in the Very-low-birth-weight Infant

NCT01208493 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-03-26

No results posted yet for this study

Summary

In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.

Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed.

After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.

Conditions

  • Prematurity

Interventions

OTHER

preterm infant formula with high protein levels

minimum 3 weeks feeding until hospital discharge

OTHER

preterm standard infant formula

minimum 3 weeks feeding until hospital discharge

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Richard J Cooke, MD · Department of Pediatrics St Louis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-12-31
Completion
2012-04-30

Countries

  • United States
  • Belgium
  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01208493 on ClinicalTrials.gov