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临床试验/NCT02279381
NCT02279381已完成4 期

A Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Efficacy of the Use of a Neonatal Package to Reduce Neonatal Infection in a Rural District of Pakistan

Aga Khan University1 个研究点 分布在 1 个国家目标入组 1,450 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
1,450
试验地点
1
主要终点
Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)

研究概览

简要总结

Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and essential neonatal care alone. The investigators anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.

详细描述

The global neonatal mortality burden is one of the imminent factors which derail the achievement of the MDG 4 in many developing countries including Pakistan. Four million infants infants die in their first 28 days of their lives which account for about 40% of the total under-five mortality. The burden of neonatal mortality in Pakistan is alarming as the current neonatal mortality rate (NMR) is 55 per 1000 live births, third worst in the world. The major causes of these deaths are infections, preterm births and birth asphyxia which are avoidable. Despite many initiatives the NMR remains unchanged since last decade in Pakistan.

Literature shows that low cost facility and community based interventions can reduce NMR significantly. Early neonatal care, application of chlorhexidine for cord care and Kangaroo Mother Care (KMC) have been recognized as effective intervention in reduction of neonatal morbidity and subsequently neonatal mortality in many developing countries. However these interventions have never been tested as a package and data about their combined effect is scarce both in Pakistan and developing countries.

Considering the importance of the issue and well recognized interventions we are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, KMC and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and standard neonatal care alone. We anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.

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
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent.

排除标准

  • Infants with congenital/birth defects,
  • any localized infection on the peri umbilical region at the time of birth or application of
  • any other material such as dung etc before enrollment on the cord.

研究组 & 干预措施

Intervention group A

Experimental
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers

干预措施: Chlorhexidine (Drug)

Intervention group A

Experimental
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers

干预措施: Kangaroo Mother Care (Other)

Intervention group A

Experimental
  1. Essential Neonatal Care
  2. Kangaroo mother Care
  3. Application of 4% Chlorhexidine
  4. Education and counseling for mothers and care providers

干预措施: Essential Neonatal Care (Other)

Intervention group B

Experimental
  1. Essential Neonatal Care
  2. Application of 4% Chlorhexidine
  3. Education and counseling for mothers and care providers

干预措施: Chlorhexidine (Drug)

Intervention group B

Experimental
  1. Essential Neonatal Care
  2. Application of 4% Chlorhexidine
  3. Education and counseling for mothers and care providers

干预措施: Essential Neonatal Care (Other)

Control group

Active Comparator
  1. Essential Neonatal Care
  2. Education and counseling for mothers and care providers

干预措施: Essential Neonatal Care (Other)

结局指标

主要结局

Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)

时间窗: 28 days post recruitment

Clinical presence of danger signs as per the IMNCI guidelines.

次要结局

  • Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))(28 days post recruitment)
  • Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)(28 days post recruitment)
  • Utilization of KMC Compliance, Frequency and duration(28 days post recruitment)

研究者

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

Dr Sajid Bashir Soofi

Associate Professor

Aga Khan University

研究点 (1)

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