Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 1A and 1B)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)
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 preterm infants ≥ 32 to 36 6/7 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 preterm infants ≥ 32 to 36 6/7 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 (this one) and one for infants who are ≥37 weeks gestational age. This preterm 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 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age ≥32 0/7 - 36 6/7 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 NICU admission
- •C/section
- •Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant
结局指标
主要结局
Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)
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)
Moderate or severe hypothermia at 1 hour after birth (Phase 1A)
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)
次要结局
- Any hypothermia at 1 hour after birth (Phase 1A)(1 hour after birth)
- Sepsis(1hour to 24 hours or discharge, or whichever occurs first)
- Any hypothermia at 24 hours or discharge (Phase 1B)(1 to 24 hours or discharge)
- Hyperthermia at 1 hour after birth (Phase 1A)(1 hour after birth)
- Hyperthermia at 24 hours or discharge (Phase 1B)(1 to 24 hours or discharge)
- Skin rash(1hour to 24 hours or discharge, or whichever occurs first)
- Maternal body temperature(At birth, at 1 hour, every four hours until 24 hours or discharge, whichever occurs first)
- Death(1hour to 24 hours or discharge, or whichever occurs first)
- Duration of KMC and plastic bag to infant's body temperature(During first 24 hours or discharge, or whichever occurs first)
- Hypotension, hypoglycemia or seizure(1hour to 24 hours or discharge, or whichever occurs first)
- Neonatal Intensive Care Unit admission(1hour to 24 hours or discharge, or whichever occurs first)
- Respiratory distress syndrome(1hour to 24 hours or discharge, or whichever occurs first)
研究者
Colm Travers
MD
University of Alabama at Birmingham