A community-based model of delivery of Kangaroo Mother Care forimproving child survival and brain development in Low Birth Weightnewborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Developmental outcomes:
研究概览
简要总结
Low birth weight (LBW) and or preterm infants will be identified through surveillance. Eligible infants will be randomized into the intervention and control groups. Mother in the intervention group will be supported by a ANM-like study workers assisted by ASHA-like study workers to provide Kangaroo mother care (KMC) to their babies at home. Breastfeeding support will also be provided to these mothers by ANM-like study workers. Essential newborn care will be delivered through Government workers in both groups. Survival will be measured in all enrolled infants through contacts at 1, 3, 6 and 12 months of age. Information will also be ascertained on initiation of breastfeeding, exclusive breastfeeding rates, incidence of infection in the neonatal and in the 1-5 months period. Development outcomes (Maternal Depression, Mother sense of competence, Mother-infant Bonding, Mother-infant interaction, Newborn Behaviour, Infant temperament, Brain development) will be measured at enrolment, 6weeks, 6 and 12 months of age. Growth will be measured at enrolment and at 1, 3, 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Day(s)（—）
- 性别
- All
入选标准
- •Mothers and low birth weight ≥1500gms to ≤2250gms.
排除标准
- •Birth weight <1500gms.
- •Unable to feed on offering feeds, confirmed by study team.
- •Infant has breathing problems or less active.
- •Mother does not intend to stay in study area for the next 12 months.
结局指标
主要结局
Developmental outcomes:
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of maternal depression
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of maternal sense of competence
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of mother infant bonding
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of newborn behaviour
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of infant temperament
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of mother infant interaction
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of cognitive function by Bayley scale
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
- Assessment of home environment by PROCESS
时间窗: - 6 weeks and 6 months | - 6 weeks and 12 months | - 6 weeks | - 6 months | - 6 weeks | - 6 months and 12 months | - 6 months and 12 months | - 12 months
次要结局
- - Neonatal mortality(- Early infant mortality)