Physiological-based Cord Clamping in Very Preterm Infants: a Multicentre Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 689
- 试验地点
- 10
- 主要终点
- Intact survival at NICU discharge
研究概览
简要总结
Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages. However, preterm infants needing immediate interventions for stabilisation or resuscitation were generally clamped immediately and excluded from trials, while these infants might benefit the most of DCC.
Studies in preterm lambs demonstrated that delaying cord clamping beyond ventilation onset resulted in more stable hemodynamic transition. This approach was called 'physiological-based cord clamping' (PBCC). The hypothesis of this study is that PBCC in preterm infants at birth will lead to an increase in intact survival when compared to standard care.
This study is a multicentre randomised controlled, parallel design, superiority trial, including preterm infants less than 30 weeks of gestation. The intervention is PBCC: stabilisation of the infant with the umbilical cord intact and only clamp the cord when the infant is stable. Stable is defined as the establishment of heart rate greater than 100 bpm and oxygen saturation above 85% while using supplemental oxygen lower than 40%. In the control group cord clamping will be performed time-based: infants are clamped first (at 30-60 seconds if the clinical condition allows) and then moved to the resuscitation table for further stabilisation.
The primary outcome will be intact survival at NICU discharge, defined as survival without cerebral injury (intraventricular haemorrhage ≥ grade 2 and/or periventricular leukomalacia ≥ grade 2 and/or periventricular venous infarction) and/or necrotizing enterocolitis (Bell stage ≥ 2).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at a gestational age below 30 weeks in a participating centre.
- •Parental consent (see 9.2).
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Significant congenital malformations influencing cardiopulmonary transition.
- •Signs of acute placental abruption.
- •Anterior placenta praevia or invasive placentation (accreta/percreta).
- •Birth by emergency caesarean section (ordered to be executed within 15 minutes).
- •Maternal general anaesthesia during caesarean section.
- •Twin gestation with signs of Twin Transfusion Syndrome or Twin Anaemia Polycythemia Syndrome not treated with fetoscopic laser treatment.
- •Multiple pregnancy > 2 (triplets or higher order).
- •Decision documented to give palliative neonatal care.
- •In case of twin delivery by caesarean section it is not possible to perform PBCC in both infants. Both infants will be included: the first infant will receive standard treatment and the second infant will be randomised to either PBCC or standard treatment.
结局指标
主要结局
Intact survival at NICU discharge
时间窗: From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.
Intact survival is defined as survival without major cerebral injury (IVH ≥ grade 2 and/or PVL ≥ grade 2 and/or periventricular venous infarction) and/or NEC ≥ Bell stage 2.
次要结局
- Short-term maternal outcomes(From date of randomization until five days after intervention.)
- Neurodevelopmental outcome (Motor) at 2 years corrected age(Assesment at two years corrected age.)
- Neurodevelopmental outcome (Cognitive) at 2 years corrected age(Assesment at two years corrected age.)
- Rate of treatment failure(From birth until one hour of age.)
- Functional outcome at 2 years corrected age(Assesment at two years corrected age.)
- Short-term neonatal outcomes(From date of randomization until the date of death or the date of NICU discharge, whichever came first, assessed up to 24 weeks.)
研究者
PasABte
Principal Investigator
Leiden University Medical Center