An Integrated Toolkit to Save Newborn Lives and Brains in Kenya
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,294
- 试验地点
- 1
- 主要终点
- Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment
研究概览
简要总结
Each year, more than 3 million neonatal deaths occur worldwide and greater than 200 million children under the age of 5, almost all in low- and middle-income countries, are not fulfilling their developmental potential. The development of the growing brain can be affected through multiple mechanisms including the same insults that are major causes of mortality, namely hypothermia and infection. The first month of life is a crucial period in neurodevelopment (ND). In this study, the investigators propose the home-based use of an integrated evidence-based toolkit to improve health status, reduce the incidence of neonatal insults that may affect brain development, decrease neonatal mortality rate (NMR), and provide early identification of danger signs. The investigators hypothesize that use of the neonatal toolkit will result in an improvement of at least one standard deviation in neurodevelopment as measured at 12 months of age by the Protocol for Child Monitoring Infant and Toddler (PCM-IT) version.
详细描述
Each year there are over 3 million global neonatal deaths. While significant progress has been made on overall under 5 mortality over the past decade, minimal progress has been made in reducing neonatal deaths and these now represent about 40% of all deaths in children under the age of 5. The majority of neonatal deaths occur in rural areas of developing countries and approximately two thirds are due to infection and complications relating to low birth weight (LBW) and prematurity. Additionally, more than 200 million children under 5 years old, almost all in low- and middle-income countries (LMIC), are not fulfilling their developmental potential. To date, most neonatal intervention trials in LMIC have focused on reducing mortality and little research has been performed on the consequences of severe but non-fatal neonatal insults on neurodevelopment (ND). Subsequently, little is known about interventions that may reduce the risk of long-term neurocognitive sequelae.
The first month of life is a critical period in ND in which there is significant neurogenesis, synaptogenesis, and myelination. Stimulation of the infant's brain during this period may have significant downstream positive effects. Development of the growing brain can be affected through multiple mechanisms including the same insults that are major causes of mortality, namely hypothermia and infection. Reducing the incidence of these insults during this period may not only save lives but also save brains and improve ND outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •i. All pregnant women in parts of study clusters covered by CHW program and their home- or facility-born live newborns.
- •ii. Mothers intending to maintain residence in study area for first 12 months of newborn's life.
排除标准
- •i. Failure to provide consent to enroll in study (intervention or control clusters).
研究组 & 干预措施
Neonatal Kit
Mothers in the neonatal kit clusters will receive a neonatal kit and training on how to use the kit components during their third trimester of pregnancy. The kit will contain a clean birth kit to be used at the time of delivery either at home or in a facility, 4% chlorhexidine (CHX) lotion, sunflower oil emollient, ThermoSpot, a Mylar infant sleeve, and a reusable, non-electric, heating device. Community Health Workers will be equipped with a hand-held battery operated scale to identify low birth weight newborns.
干预措施: Neonatal Kit (Device)
Neonatal Stimulation
During home visits in the 3rd trimester, mothers in the neonatal stimulation clusters will be taught 3 core messages pertaining to neonatal stimulation. First, mothers will be taught how to make eye contact and talk to their child. This type of interaction encourages social inclusion, attachment, and development of social-communication skills. Second, mothers will be taught techniques to foster responsive feeding and caregiving. Finally, mothers will be encouraged to sing songs and nursery rhymes, including those with gentle touch in order to support the development of communication skills, and introduce a tactile component to caregiving. These messages will be reiterated at subsequent home visits by the CHW after the baby is born.
干预措施: Neonatal Stimulation (Behavioral)
Neonatal Kit and Neonatal Stimulation
Participants in this arm of the study will receive both a neonatal kit (described in Arm 1) and neonatal stimulation (described in Arm 2).
干预措施: Neonatal Kit (Device)
Neonatal Kit and Neonatal Stimulation
Participants in this arm of the study will receive both a neonatal kit (described in Arm 1) and neonatal stimulation (described in Arm 2).
干预措施: Neonatal Stimulation (Behavioral)
Control (Standard Care)
In control clusters, CHWs will visit the home according to the regular schedule (same as in the intervention clusters) and deliver the standard CHW post-natal care that consists of talking to mothers about:
- Exclusive breastfeeding and proper nutrition for both the mother and the baby.
- Ensuring warmth to the baby.
- Full immunization and growth monitoring of newborn.
- Hygiene and sanitation practices.
- Family Planning and promote the proper use of Insecticides Treated Nets.
- Identifying any danger sign/complication for both mothers and new-borns and refer for prompt treatment (within 24 hours) for management and treatment.
- Promoting the use of services such as birth registration.
- Giving advice on proper care of the umbilical cord.
结局指标
主要结局
Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment
时间窗: 12 months of age
The Protocol for Child Monitoring - Infant and Toddler (PCM-IT) version was designed in Kenya to assess neurodevelopment in resource-limited settings.
次要结局
- Incidence of omphalitis(Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life)
- Neonatal mortality(Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life)
- Number of LBW babies identified(Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life)
- Incidence of severe infection(Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life)
- Cases of hypothermia identified(Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life)
- Cases of hyperthermia identified(Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life)
- Health facility use(Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life)
研究者
Shaun Morris
Associate Staff Physician
The Hospital for Sick Children