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

Completed · Not applicable

Conditions studied: Infant, Very Low Birth Weight

In brief

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.

Key facts

Study ID

NCT00506584

Run by

Prolacta Bioscience

People needed

260

Starts

2007-07-01

Expected to finish

2008-07-01

Last updated by the study team

2010-02-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth weight between 500 and 1250g.
• Have a reasonable expectation of survival for the maximum 90 day duration of the study.
• In "Study Group 1", must be able to adhere to a feeding protocol involving mother's own milk and that may include donor human milk with fortification using a human-based product (Prolact+4) or fortification with a bovine-based human milk fortifier and the use of a pre-term/term formula; or in "Study Group 2" the use of donor human milk with Prolact+4 or a pre-term/term formula from the time that the infant initiates enteral feeding through day 90 of life, until discharge from the study institution, discharge home, death or the initiation of at least 50% total oral nutrition (4 complete feeds in a 24 hour period), whichever comes first.
• Enteral feeding must begin before the 21st day of life.
• Total parenteral nutrition (TPN) initiated within 48 hours after birth.
• Informed consent obtained from parent or legal guardian.

You may not qualify if…

• Less than a reasonable expectation of survival for the infant's particular gestational age through the study period (first 90 days of life, discharge to a non-study institution, discharge home, death or initiation of 50% oral nutrition, whichever comes first).
• On any other clinical study affecting nutritional management during the study period.
• Decision to not start minimum enteral feed before day 21 of life.
• Decision to not start TPN within the first 48 hours after birth.
• Unable to obtain informed consent from parent or legal guardian prior to the initiation of enteral feeding.
• Presence of clinically significant congenital heart disease.
• Presence of any major congenital malformations.
• Reasonable potential for early transfer to a non-study institution.
• Unable to participate for any reason based on the decision of the study investigator.

Where it is running

• 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
• Innsbruck Children's Hospital — Innsbruck, Austria

Full record on ClinicalTrials.gov

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