A Community-based Model of Delivery of Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Assessment of maternal sense of competence
研究概览
简要总结
While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and potentially neurodevelopment, in preterm and low birth weight infants in hospital settings but its coverage remains low. Innovation is required to allow the community-based delivery of KMC by front-line workers. This could greatly accelerate scale up and sustainability of this intervention in low resource settings.
The proposed randomized trial is planned in a setting where 40% of births take place at home. Early discharge (as early as within 12 hours of birth) is common for facility births, often at the request of families for social and cultural reasons. Many of the hospitals do not have incubators for the care of very small babies.
详细描述
Low birth weight (LBW) 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, Maternal 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control
Routine visits by government health workers
干预措施: Essential newborn care (Other)
Intervention KMC
Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers
干预措施: KMC (Behavioral)
Intervention KMC
Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers
干预措施: Essential newborn care (Other)
结局指标
主要结局
Assessment of maternal sense of competence
时间窗: Assessment of maternal sense of competence at 12 months
Maternal sense of competence will be measured by maternal self efficacy questionnaire
Assessment of newborn behaviour
时间窗: 6 weeks
Assessment of newborn behaviour by Neonatal behavioural assessment scale
Assessment of mother infant interaction
时间窗: 6 months
Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task
Assessment of cognitive function by Bayley scale
时间窗: Assessment of cognitive function by Bayley scale at 12 months
Assessment of home environment by PROCESS
时间窗: 12 months
Assessment of maternal depression
时间窗: Assessment of maternal depression at 6 months
The depression will be measured using patient health questionnaire-9
Assessment of mother infant bonding
时间窗: 6 weeks
Mother infant bonding will be measured by maternal postnatal attachment questionnaire
Assessment of infant temperament
时间窗: Assessment of infant temperament at 12 months
Assessment of infant temperament by infant temperament scale
次要结局
- Early initiation of breastfeeding(From birth to 1 month)
- Early and appropriate care seeking practices at 3 months(Assessed at 3 months data from 1 month upto 3 months)
- Early recognition of illness at 3 months(Assessed at 3 months data from 1 month upto 3 months)
- Neonatal mortality(From birth to 28 days)
- Early and appropriate care seeking practices at 1 month(1 month period)
- Weight and length gain(1, 3, 6 and 12 months)
- Early recognition of illness at 1 month(1 month period)
- Early infant mortality(From birth to 6 months)
- Proportion exclusively breastfed(1, 3 and 6 months)
- Incidence of infection in neonatal(1 month period)
- Early recognition of illness at 6 months(Assessed at 6 months data from 3 months upto 6 months)
- Early and appropriate care seeking practices at 6 months(Assessed at 6 months data from 3 months upto 6 months)