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临床试验/NCT00097097
NCT00097097已完成3 期

Neonatal Resuscitation in Zambia

NICHD Global Network for Women's and Children's Health1 个研究点 分布在 1 个国家目标入组 40,000 人开始时间: 2004年10月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40,000
试验地点
1
主要终点
Neonatal mortality at 7 days

研究概览

简要总结

Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

详细描述

Birth asphyxia (defined as "failure to initiate and sustain breathing at birth") has been identified by the World Health Organization (WHO) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia, the WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. The Neonatal Resuscitation Program (NRP) has been universally accepted in the developed world but has had limited dissemination in many developing countries, including Zambia. The primary hypothesis of this study is that implementation of the combined Neonatal Resuscitation Program/WHO Essential Newborn Care (ENC) Program, compared to basic neonatal care education of health care providers (ENC only) will result in reduced neonatal 7-day mortality. This trial will be performed in two Zambian cities: Lusaka and Ndola. Training in data collection will be conducted in order to establish baseline data on mortality and asphyxia. Following this time period, all centers will receive the ENC training and continue to collect data for 7 months. The clinics will then receive NRP Training and collect data for a 12-month period.

The primary outcome will be a decrease in neonatal 7-day mortality following the NRP training when compared to the ENC-only time period. Secondary outcomes will include neonatal mortality due to perinatal asphyxia, mortality or hypoxic ischemic encephalopathy (HIE) at 7 days, need for advanced resuscitation, Apgar scores at 5 minutes, sustainability of the program, as well as providers' self efficacy, competence, and performance in neonatal resuscitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Live birth infants with birth weight ≥ 1500 g
  • Infants who are born at participating health centers in Lusaka and Ndola, Zambia
  • No lethal malformations

排除标准

  • Stillbirths
  • Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired)
  • Any infant who is transported/brought to the center after delivery

结局指标

主要结局

Neonatal mortality at 7 days

次要结局

  • Neonatal mortality due to perinatal asphyxia
  • Self efficacy, knowledge, performance, and competence in neonatal resuscitation
  • Apgar scores at 5 minutes

研究者

发起方
NICHD Global Network for Women's and Children's Health
申办方类型
Network
责任方
Sponsor

研究点 (1)

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