SAVE (Sustained Cord Circulation Awaiting VEntilation)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Apgar score
研究概览
简要总结
This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.
详细描述
The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator.
It has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition.
Because of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnancy week ≥35 + 0
- •Singletons
- •Expected vaginal delivery
- •The woman / couple can adequately assimilate information about the study
- •Signed informed consent of both prospective parents
排除标准
- •Congenital malformation that complicates resuscitation (such as severe malformation of mouth, pharynx, respiratory system) or which causes the child not to be resuscitated due to internal structural malformations (such as more severe heart failure, diaphragm fractures, etc.)
- •The child is born via acute caesarean section after inclusion and opening of study envelope
- •placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)
结局指标
主要结局
Apgar score
时间窗: At 5 minutes after birth
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.
次要结局
- Need of neonatal intensive care(7 days)
- Mortality(One year)
- Morbidity Assessment Index for Newborns (MAIN)(7 days)
- Blood glucose(4 hours after birth)
- Breathing difficulties(6 hours after birth)
- Presence at one day of age(24 hours)
- Apgar score(At 10 minute after birth)
- Development(54 months)
- Time of first cry or breathing effort(Within 10 minutes after birth)
- Time of establishing spontaneous breathing(Within 10 minutes after birth)
- Score for Neonatal Acute Physiology (SNAP-II)(7 days)
- Autism(24 months)
- Motor development(54 months)