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The study will be a large randomized controlled trial to assess the efficacy and safety of neonatal vitamin A supplementation administered to neonates once orally either on the day of birth or in the next 2 days in improving infant survival in the first 6 months of life.
The study will be an individually randomized trial conducted in two districts in the state of Haryana.
Community informants will report births to the enrollment team. At enrollment, the team will explain the study to the family and in those willing, written consent will be obtained from the parents of the infant. The infant will be given the dose of vitamin A/placebo and a form containing baseline socioeconomic characteristics and information on feeding practices of the infant and mother will be filled.
After enrollment, each infant will be visited by the enrollment team at hospital or home 1 day and 3 days after supplementation to document any illnesses in the baby. Newborns with illnesses will be referred/escorted to the nearest health facility for management.
Each enrolled infant will be visited when aged 29 days, 3, and 6 months to document vital status and hospitalizations since the last visit. Information on feeding practices will also be obtained. For all deaths, verbal autopsy interviews will be conducted.
Blood specimens will be obtained in a subsample of infants at 2 weeks and 3 months of age and in a subsample of mothers at 3 months of age.
Quality control activities include independent and supervised checks and will be conducted for a subsample by a separate team.
A DSMB has been constituted for the study. All deaths occurring within 3 days of supplementation will be reported to the SAS IRB and to the WHO Coordinating Unit.
Similar trials are being funded by the World Health Organization (Geneva) in Ghana and Tanzania.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Neonatal Vitamin A Supplementation
Society for Applied Studies
Society for Applied Studies
Published on BioPortfolio: 2014-08-27T03:13:08-0400
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