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The MILK Trial for Premature Babies - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if donor breast milk offers premature babies the same benefits as the mother's breast milk. 

What is the Condition Being Studied?

Brain development of very premature babies

Who Can Participate in the Study?

Babies who:
- Were born at less than 29 weeks gestation
- May be born in the hospital or admitted by transport before 7 days of age
- Do not have any disorders known to interfere with feeding

Age Group
Children

What is Involved?

If you decide to join this study, your baby will:  
- Be randomized, like the flip of a coin, to be in one of two groups:
-- Sole Diet Group babies will receive either donor breastmilk or preterm formula as the sole in-hospital diet from the time of randomization until close to discharge
-- Supplemental Diet Group babies will receive either donor breastmilk or preterm formula in addition to their mother's breast milk 
- Have a follow-up visit between the age of 22 and 26 months.
-- During this visit, your baby will have a medical exam, developmental testing, and weight, length, and head circumference checked.

Study Details

Full Title
Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in ELBW Infants
Principal Investigator
Protocol Number
IRB:PRO00035310
NCT:NCT01534481
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698