Early or Late Cord Clamping in the Depressed Neonate - a Randomized Controlled Study in a Low-income Facility Setting for Improved Early Neonatal Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Blood oxygen saturation
研究概览
简要总结
This study evaluates the hypothesis that delayed compared to early umbilical cord clamping will improve neonatal transition in terms of circulation and breathing during resuscitation.
详细描述
At the time of birth, the infant is still attached to the placenta via the umbilical cord. The infant is usually separated from the placenta by clamping the cord with two clamps. Early cord clamping has been generally advised to be carried out in the first 30 seconds after birth, regardless of whether the cord pulsation has ceased. However, arguments against early cord clamping include the reduction in the amount of placental transfusion and any associated benefits of extra blood volume, as delayed clamping allows time for a transfer of the fetal blood in the placenta to the infant at the time of birth.
The study will evaluate the effect of early versus delayed cord clamping in a low-income setting in children that do not spontaneously start to breathe. The randomized controlled trial will be carried out at Paropakar Maternity and Women's Hospital (PMWH) in Kathmandu.
The trial will fill several important gaps in relation to early and delayed cord clamping and results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 33 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn in need of resuscitation measures (no or irregular breathing despite thorough drying and additional stimulation within one minute after birth)
- •Gestational age ≥ 33 weeks
排除标准
- •Monochorionic twins (from an ultrasound scan) or clinical evidence of twin-twin transfusion syndrome, triplets or higher order multiple pregnancy, and fetuses with known congenital malformation
结局指标
主要结局
Blood oxygen saturation
时间窗: 10 minutes after birth
Measured with a pulse oximeter
次要结局
- Apgar score(At 10 minutes after birth)
- Timing of establishing spontaneous breathing(Within 10 minutes after birth)
- Blood oxygen saturation(5 minutes after birth)
- Rectal temperature(At 30 minutes after birth)
- Pulsatility index(At 10 minutes after birth)
- Timing of moving baby from mother to resuscitation table (if applicable(Within 10 minutes after birth)
- Timing of reaching > 90 % in oxygen saturation(Within 10 minutes after birth)
- Newborn heart rate(At 10 minutes after birth)
- Timing of first cry(Within 10 minutes after birth)