Placing Preterm Infants in Polyethylene Bags Immediately After Birth
试验速览
- 阶段
- 不适用
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Temperature on admission to the Neonatal Intensive Care Unit (NICU)
研究概览
简要总结
Primary objective: To determine if placing preterm infants in a polyethylene bag (PB) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on admission to the Neonatal Intensive Care Unit (NICU).
详细描述
Newly born preterm infants that develop abnormal temperature after birth have higher morbidity and mortality. Placing infants < 32 weeks' gestation in a polyethylene bag (PB) in the delivery room (DR) reduces the rate of hypothermia on admission to the Neonatal Intensive Care Unit (NICU). Since 2012, the rate of admission hypothermia in preterm infants, placed in a PB in the DR at the National Maternity Hospital (NMH), has increased significantly. This may be as a result of heat loss while the infant remains attached to the cord.
Our primary objective is to determine if placing preterm infants in a PB immediately after birth, before the umbilical cord is clamped will increase the number of preterm infants with a normal temperature on admission to the NICU.
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
- Double (Participant, Outcomes Assessor)
盲法说明
In the delivery room, the infant is randomised to application of a polyethylene bag before or after cord clamping. Neither the delivery room care provider nor the investigator are blinded to the group assignment. When the infant is stable, they are be transferred from the delivery room to the neonatal unit. The outcome assessor is the admitting nurse in the neonatal unit who will be blinded to the group assignment.
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants who are inborn at the National Maternity Hospital at < 32 (up to 31+6) weeks' gestation by best obstetric estimate will be included in the study.
排除标准
- •Infants with a large abdominal wall or neural tube defects
- •Infants with an imperforate anus
- •Infants to whom resuscitative measures are not initiated in the DR
研究组 & 干预措施
PB BCC: Polyethylene Bag Before Cord Clamping
Immediately after delivery, while still attached to placental circulation, infants will be placed in a PB. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire for ongoing care. In the case of caesarean section a sterile bag will be used and prepared observing sterile techniques. A member of the neonatal team donned in sterile gown and gloves will assist the obstetrician in placing the infant in the PB.
干预措施: Polyethylene bag before the umbilical cord is clamped (Other)
PB ACC: Polyethylene Bag After Cord Clamping
Infants will not be placed in a PB immediately after birth. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire where they will be placed in a PB.
结局指标
主要结局
Temperature on admission to the Neonatal Intensive Care Unit (NICU)
时间窗: The primary outcome measure will be determined on admission to the NICU, before the infant is removed from the transport incubator (< 90minutes of life)
Rectal temperature recorded upon arrival to the NICU, while the infant is in the transport incubator. (measured in degrees celsius)
次要结局
- Death before discharge from hospital(Term corrected gestation age or hospital discharge (<17 weeks))
- Infant temperature recordings in the delivery room(Within 2 hours of birth)
- External cardiac massage in the delivery room(Within 2 hours of birth)
- Hypotension requiring inotropes(Term corrected gestation age or hospital discharge (<17 weeks))
- Respiratory support in the DR(Within 2 hours of birth)
- Axillary temperature on admission to the NICU(Between 0-2 hours of life)
- Intubation and mechanical ventilation(Term corrected gestation age or hospital discharge (<17 weeks))
- Pulmonary haemorrhage(Term corrected gestation age or hospital discharge (<17 weeks))
- Necrotising enterocolitis(Term corrected gestation age or hospital discharge (<17 weeks))
- 5 minute Apgar(Within 2 hours of birth)
- Central catheter placement in first 24 hours(Between 0-24 hours of life)
- Surfactant administration(Day 1 - 7 of life)
- Intraventricular haemorrhage(Term corrected gestation age or hospital discharge (<17 weeks))
- Respiratory Distress Syndrome(Between 0-24 hours of life)
- Pneumothorax requiring drainage(Term corrected gestation age or hospital discharge (<17 weeks))
- Retinopathy of prematurity requiring treatment(Term corrected gestation age or hospital discharge (<17 weeks))
- Temperature 1 hour after admission(Between 0-2 hours of life)
- Non-invasive ventilation (NIV) on the first day of life (24 hours)(Between 0-24 hours of life)
- Sepsis - early onset(Between 0-72 hours of life)
- Sepsis - late onset(After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks))
- Periventricular leukomalacia(Term corrected gestation age or hospital discharge (<17 weeks))
- Oxygen requirement at 36 weeks corrected gestational age(36 weeks corrected gestational age)