A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Axillary temperature < 36.0 degrees Celsius
研究概览
简要总结
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.
详细描述
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0 degrees C) in preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.
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 Minute 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated gestational age 32-36 6/7 weeks
- •Delivery in the hospital
排除标准
- •Abdominal wall defect or myelomeningocele
- •Major congenital anomalies
- •Blistering skin disorder
研究组 & 干预措施
Continuous Kangaroo Mother Care to 1 hour after birth
In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth.
干预措施: Continuous Kangaroo Mother Care to 1 hour after birth (Other)
Standard Kangaroo Mother Care to 1 hour after birth
Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth.
干预措施: Standard Kangaroo Mother Care to 1 hour after birth (Other)
Continuous Kangaroo Mother Care to discharge
In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge.
干预措施: Continuous Kangaroo Mother Care to discharge (Other)
Standard Kangaroo Mother Care to discharge
Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge.
干预措施: Standard Kangaroo Mother Care to discharge (Other)
结局指标
主要结局
Axillary temperature < 36.0 degrees Celsius
时间窗: Time of birth to 1 hour
Temperature taken per axilla for one minute
Axillary Temperature < 36.0 degrees Celsius
时间窗: At discharge or 24 hours after birth (whichever is first)
Temperature taken per axilla for one minute
次要结局
- Blood pressure(Duration of hospitalization-expected average of 4 weeks)
- Respiratory Distress Syndrome (RDS)(Duration of hospitalization-expected average of 4 weeks)
- Blood glucose(Duration of hospitalization-expected average of 4 weeks)
- Seizure(Duration of hospitalization-expected average of 4 weeks)
- Sepsis(Duration of hospitalization-expected average of 4 weeks)
- Neonatal Intensive Care Unit Admission(Duration of hospitalization-expected average of 4 weeks)
- Death(Duration of hospitalization-expected average of 4 weeks)
- Any Axillary Temperature < 36.0 degrees Celsius(Duration of hospitalization-expected average of 4 weeks)
- Duration of Kangaroo Mother Care(Duration of hospitalization-expected average 4 weeks)
研究者
Manimaran Ramani, MD
Assistant Professor of Pediatrics
University of Alabama at Birmingham