This clinical trial will compare how the individualized and fortified human milk feeding will
help a premature infant grow.
: human milk fortifier
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Locations near you
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Full eligibility criteria for NCT01731613
Ages eligible for Study
up to 40 Days
Genders eligible for Study
Accepts Healthy Volunteers
Less than 34 weeks gestational age at birth
Birth weight within 800-1800 grams
Exclusively or mostly breastfed (greater than 80% if the feeding volume)
Tolerated enteral feedings of 60 ml/kg/d
Remain in the Neonatal Intensive Care Unit at least 14 days prior to hospital discharge,remain in the Neonatal Intensive Care Unit at least 10 days after enrollment
Signed Informed Consent
Small for gestational age
Infants currently receiving ventilation therapy
Major congenital malformations
Suspected or documented systemic or congenital infections
Evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth
Severe intraventricular hemorrhage (greater than grade II) or periventricular leukomalacia
Suspected or documented maternal substance abuse
Infants currently receiving glucocorticoids or infants who have received glucocorticoids within the past 28 days
All locations for NCT01731613
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
View full eligibility
Tris trial is registered with FDA with number: NCT01731613. The sponsor of the trial is Peking Union Medical College Hospital and it is looking for 51 volunteers for the current phase.
Official trial title: Adjustable Fortification of Human Milk Fed to Chinese Preterm Infants
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