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Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants

NCT00506584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2010-02-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better health outcomes than babies fed at least some formula (made from cow's milk)or formula-derived nutrition.

Conditions

  • Infant, Very Low Birth Weight

Interventions

DIETARY_SUPPLEMENT

Pasteurized human milk and pasteurized human milk fortifier

Human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day

DIETARY_SUPPLEMENT

Pasteurized human milk and pasteurized human milk fortifier

Human milk fortifier is initiated when nutrition volume reaches 40 mL/kg/day

DIETARY_SUPPLEMENT

Human milk fortifier (bovine-based), pre-term formula

Bovine-based human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day

DIETARY_SUPPLEMENT

Pasteurized human milk and pasteurized human milk fortifier

Human milk fortifier initiated when nutrition volume reaches 100 mL/kg/day

DIETARY_SUPPLEMENT

Pre-term/term formula

Bovine milk-derived nutrition formulated for very low birth weight infants

Sponsors & Collaborators

  • Prolacta Bioscience

    lead INDUSTRY

Principal Investigators

  • Richard J Schanler, MD · Schneider Children's Hospital at North Shore

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Austria

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 NCT00506584 on ClinicalTrials.gov