Clinical trialNCT00506584CompletedInterventional

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

SponsorProlacta BioscienceEnrollment260Infant, Very Low Birth Weight

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Richard J Schanler, MD
Schneider Children's Hospital at North Shore
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria

Innsbruck Children'S Hospital
Innsbruck, Austria

United States

Alta Bates Summit Medical Center
Berkeley, California, United States
University of California, San Diego Medical Center
San Diego, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Shands Children'S Hospital
Gainesville, Florida, United States
Rush-Presbyterian St. Luke'S Medical Center
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Schneider Children'S Hospital at North Shore
Manhasset, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ben Taub Hospital/baylor College of Medicine
Houston, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jul 2007
Primary completion: 31 Jul 2008
Completion: 31 Jul 2008
Last update posted: 18 Feb 2010
Registered enrollment: 260
Registry id: NCT00506584

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.