跳至主要内容
临床试验/NCT03141723
NCT03141723已完成不适用

Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 423 人开始时间: 2017年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
423
试验地点
1
主要终点
Moderate or severe hypothermia at 1 hour after birth (Phase 2A)

研究概览

简要总结

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

详细描述

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° C) or severe (<32.0° C) in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care, as practiced. The investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks and one for infants who are ≥37 weeks gestational age (this one). This term infant trial will address the effectiveness of KMC in combination with plastic bags in decreasing hypothermia in preterm infants. The proposed trial will determine whether KMC with plastic bags prevents hypothermia in neonates born in a healthcare setting with limited resources where a high risk for hypothermia has been reported. Any intervention that decreases morbidity during the neonatal period has the potential to impact health beyond the neonatal period,and one that is highly cost-effective and easy to use is more likely to be implemented in the developing world.

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
10 Minutes 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Estimated gestational age ≥37 0/7 weeks
  • Delivery in the hospital

排除标准

  • Abdominal wall defect or myelomeningocele
  • Major congenital anomalies
  • Blistering skin disorder
  • Clinically unstable mothers secondary to cardiovascular and pulmonary conditions
  • Infants requiring respiratory support beyond 10 minutes after birth
  • Infant requiring Neonatal Intensive Care Unit admission
  • Cesarean section
  • Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant

研究组 & 干预措施

KMC & WHO protocol (0-1 hour)

Active Comparator

The combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.

干预措施: KMC & WHO protocol (0-1 hour) (Other)

KMC & WHO protocol (1-24 hours)

Active Comparator

The combination of Kangaroo Mother Care (KMC) as continuously as possible together with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.

干预措施: KMC & WHO protocol (1-24 hours) (Other)

KMC, WHO protocol & bag (0-1 hour)

Experimental

The combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.

干预措施: KMC, WHO protocol & bag (0-1 hour) (Other)

KMC, WHO protocol & bag (1-24 hours

Experimental

The combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.

干预措施: KMC, WHO protocol & bag (1-24 hours) (Other)

结局指标

主要结局

Moderate or severe hypothermia at 1 hour after birth (Phase 2A)

时间窗: 1 hour after birth

Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 1 hour after birth (via axillary temperature)

Moderate or severe hypothermia at 24 hours or discharge (Phase 2B)

时间窗: 1 to 24 hours after birth

Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)

次要结局

  • Hypotension, hypoglycemia or seizure(1 hour to 24 hours or discharge, or whichever occurs first)
  • Hyperthermia at 1 hour after birth (Phase 2A)(1 hour after birth)
  • Hyperthermia at 1 hour after birth (Phase 2B)(1 to 24 hours or discharge)
  • Skin rash(1 hour to 24 hours or discharge, or whichever occurs first)
  • Respiratory distress syndrome(1 hour to 24 hours or discharge, or whichever occurs first)
  • Sepsis(1 hour to 24 hours or discharge, or whichever occurs first)
  • Death(1 hour to 24 hours or discharge, or whichever occurs first)
  • Maternal body temperature(At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first)
  • Duration of KMC and plastic bag to infant's body temperature(During first 24 hours or discharge, or whichever occurs first])
  • Any hypothermia at 1 hour after birth (Phase 2B)(1 to 24 hours or discharge)
  • Neonatal Intensive Care Unit admission(1 hour to 24 hours or discharge, or whichever occurs first)
  • Any hypothermia at 1 hour after birth (Phase 2A)(1 hour after birth)

研究者

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

Colm Travers

MD

University of Alabama at Birmingham

研究点 (1)

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