This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
Enteral, 150 mg/kg twice per day
Oral, twice per day
Childrens Hospital of Los Angeles
Los Angeles, California, United States
RECRUITINGKosair Children's Hospital
Louisville, Kentucky, United States
RECRUITINGUniversity of Louisville Hospital
Louisville, Kentucky, United States
Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP)
Time frame: 1-3 months
"NEC Scares", the "Neonatal Sepsis Syndrome"
Time frame: 1-3 months
Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU
Time frame: 1-3 months
Mortality during hospitalization
Time frame: 1-3 months
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University of Missouri Health Care, Columbia Regional Hospital
Columbia, Missouri, United States
RECRUITING