Sustained Cord Circulation at Emergency Cesarean Section - a New Concept for Resuscitating Neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 2,200
- 试验地点
- 13
- 主要终点
- Composite outcome of admission to neonatal care for predefined criteria and death before admission.
研究概览
简要总结
The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section. The main question it aims to answer is: Does sustained cord circulation reduce admission rates to neonatal care?
Researchers will compare resuscitation with an uncut umblical cord to standard resuscitation practices to see if it provides better outcomes.
Participants (term neonates born by emergency Cesarean section) will:
Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes
详细描述
Study Title
Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section: A Multicenter Randomized Controlled Trial
Primary Objectives:
To compare neonatal outcomes between two different approaches to resuscitation of term neonates born by CS; Intact cord resuscitation versus standard care with immediate cord clamping, and evaluate:
A composite outcome of admission to neonatal care for predefined criteria or death before admission. Predefined criteria include asphyxia at birth, respiratory distress, hypoxic ischemic encephalopathy (HIE) and hypoglycemia. Assessed within one week after birth.
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
- None
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Singleton neonate
- •Born alive
- •Gestational age ≥37 weeks
- •Born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric/neonatal team has been called for to attend.
排除标准
- •Major congenital malformation that may affect resuscitation or outcome measures.
- •Major genetic disorder that may affect resuscitation or outcome measures.
结局指标
主要结局
Composite outcome of admission to neonatal care for predefined criteria and death before admission.
时间窗: At one hour after birth
Admission to neonatal care is collected from the Swedish Neonatal Quality registry (SNQ), as are criteria for admission:• Asphyxia at birth (One-, Five- and/or Ten-minute Apgar score \<4), diagnosis P21.0, P21.1A, P21.1B or P21.9.• Respiratory distress (Noted in SNQ as NAS, neonatal respiratory distress P22.8, PAS, pulmonary adaption disturbance P 22.1, RDS, respiratory distress syndrome P22.0, MAS meconium aspiration syndrome P24.0, PPHN, Persistant Pulmonary Hypertension P29.3B, or PTX, Pneumothorax P25.1).• Hypoxic-ischemic encephalopathy grade I-III, P91.6A, B, C, or X.• Hypoglycemia, P 70.4A, or B. Death of the neonate before admission is collected from Swedish pregnancy registry. Units of measure is dichotomous, as appearance of the diagnoses or not.
次要结局
- Apgar score at 5 min(5 minutes)
- Apgar score at 10 min(10 minutes)
- Respiratory distress as a diagnosis after birth(One week after birth)
- Hypoxic-ischemic encephalopathy as a diagnosis after birth(One week after birth)
- Hypoglycemia as a diagnosis after birth(One week after birth)
- Duration of neonatal care(One month)
- Death after birth but before admission to neonatal unit(One hour after birth)
- Apgar score at 5 min(5 minutes)
- Apgar score at 10 min(10 minutes)
- Respiratory distress as a diagnosis after birth(One week after birth)
- Hypoxic-ischemic encephalopathy as a diagnosis after birth(One week after birth)
- Hypoglycemia as a diagnosis after birth(One week after birth)
- Duration of neonatal care(One month)
- Death after birth but before admission to neonatal unit(One hour after birth)