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临床试验/NCT02208960
NCT02208960已完成3 期

An Integrated Toolkit to Save Newborn Lives and Brains in Kenya

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 2,294 人开始时间: 2014年11月最近更新:
适应症

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

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).

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaun Morris

Associate Staff Physician

The Hospital for Sick Children

研究点 (1)

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