Efficacy of Neonatal Vitamin A Supplementation in Improving Child Survival in Haryana, India: Generation of Evidence Necessary for Informing Global Policy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44,984
- 试验地点
- 1
- 主要终点
- Risk of death
研究概览
简要总结
The study is 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.
详细描述
The study is an individually randomized trial conducted in two districts in the state of Haryana.
Community informants report births to the enrolment team. At enrolment, the team explains the study to the family and in those willing, written consent is obtained from the parents of the infant. The infant is given the dose of vitamin A/placebo and a form containing baseline socioeconomic characteristics and information on feeding practices of the infant and mother is filled.
After enrollment, each infant is 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 are referred/escorted to the nearest health facility for management.
Enrolled infants are visited when aged 29 days, 3, 6 and 12 months to document vital status and hospitalizations since the last visit. Information on feeding practices, immunization, maternal intake of vitamin A rich foods and supplements, and intake of any supplement containing vitamin A by the infant is recorded at these visits. Subgroup analyses includes the effect of vitamin A supplementation in LBW and non LBW infants, male and female infants, immunized and unimmunized infants, infants of families in the poorest and richest quintiles and by vitamin A intake of mothers. For all deaths, verbal autopsy interviews are conducted.
Blood specimens are 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent to participate
- •All births in the study area that are contacted by enrolment team within the eligible age window
排除标准
- •Unable to feed on offering feeds, as reported by the mother
- •Mother does not intend to stay in the study area for at least 6 months
研究组 & 干预措施
Vitamin A
Vitamin A capsules have retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil
干预措施: Vitamin A (Drug)
Placebo
Placebo capsules contain minute amounts of vitamin E in soybean oil
干预措施: Vitamin A (Drug)
结局指标
主要结局
Risk of death
时间窗: Period between receiving the intervention/placebo and six months of age
To determine if vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days will reduce mortality in the first half of infancy as compared to placebo.
次要结局
- Risk of death(Period between receiving the intervention/placebo and 12 months of age)
- Vitamin A status in a subgroup of newborns and caregivers in the intervention and placebo groups(Two weeks and three months of age)
- Risk of hospital admission(Period between receiving the intervention/placebo and six months of age)
- Bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that caused parents to be concerned(Three day period following supplementation)
研究者
NBhandari
Director
Society for Applied Studies