Status:
COMPLETED
Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Bill and Melinda Gates Foundation
United States Agency for International Development (USAID)
Conditions:
Sepsis
Necrotizing Enterocolitis
Eligibility:
All Genders
1-28 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine whether vitamin A can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.
Detailed Description
Sepsis and necrotizing enterocolitis (NEC) are leading causes of morbidity and mortality in neonates. Studies have shown that early reversal of the signs associated with severe disease is an important...
Eligibility Criteria
Inclusion
- newborns less than 29 days with clinical sepsis
Exclusion
- healthy infants
- major congenital abnormalities
- known inborn error(s) of metabolism
- chronic disorders of other organs (e.g. cholestasis)
- definite or severe NEC (\> stage 2)
- congenital heart disease
- Infants receiving VA supplements
- Infants requiring mechanical ventilation
- Infant is unconscious
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT00707785
Start Date
December 1 2006
End Date
June 1 2012
Last Update
September 25 2013
Active Locations (1)
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1
Dhaka Shishu Hospital
Dhaka, Bangladesh