先天性膈疝的生理学脐带夹紧 (PinC)
先天性膈疝婴儿的生理性脐带夹紧与立即脐带夹紧：一项多中心、随机对照试验
Pulmonary hypertension is a major determinant of postnatal survival in infants with a congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation period in infants born with this rare birth defect might contribute to the development of pulmonary hypertension after birth - in particular umbilical cord clamping before lung aeration. An ovine model of diaphragmatic hernia demonstrated that cord clamping after lung aeration, called physiological-based cord clamping (PBCC), avoided the initial high pressures in the lung vasculature while maintaining adequate blood flow, thereby avoiding vascular remodelling and aggravation of pulmonary hypertension. The investigators aim to investigate if the implementation of PBCC in the perinatal stabilisation period of infants born with a CDH could reduce the incidence of pulmonary hypertension in the first 24 hours after birth.
The investigators will perform a multicentre, randomised controlled trial in infants with an isolated CDH. Before birth, infants will be randomised to either PBCC or immediate cord clamping, stratified by treatment centre and severity of pulmonary hypoplasia on antenatal ultrasound. For performing PBCC a purpose-designed resuscitation module (the Concord Birth Trolley) will be used.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Graz、奥地利
- Medical University Graz
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Bonn、德国
- Universitätskrankenhaus Bonn
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Mannheim、德国
- Universitätsklinik Mannheim
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Rome、意大利
- Ospedale Pediatrico Bambino Gesu
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Leuven、比利时
- University Hospitals leuven
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Melbourne、澳大利亚
- Monash University
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Stockholm、瑞典
- Karolinska University Hospital
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Nijmegen、荷兰
- Radboudumc University Medical Center
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Rotterdam、荷兰
- Erasmus MC University Medical Center - Sophia Children's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Left-sided CDH
- Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth
- Gestational age at delivery ≥35.0 weeks
- Parental written informed consent
Exclusion Criteria:
- Right-sided or bilateral CDH
- Gestational age at delivery <35.0 weeks
- Maternal contraindications: anterior placenta praevia, placental abruption
- High urgency caesarean section, with intended interval to delivery <15 min
- Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension
- Twin pregnancies in which the infant diagnosed with a CDH is born first
- Multiple birth >2 (triplets or higher order)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Physiological-based cord clamping
In PBCC, the Concord will be placed next to the bed of the mother and all equipment will be checked before the second stage of labour has started. The infant will be placed on the platform of the Concord immediately after birth, avoiding any traction or pressure on the cord and avoiding heat loss by radiation heating. The umbilical cord will not be clamped until the infant is considered respiratory stable, which is defined as the presence of a heart rate >100 bpm and preductal oxygen saturation >85%, while using an fraction of inspired oxygen (FiO2) of <0.5. The minimum and maximum times of cord clamping are three and ten minutes after birth, respectively. Oxytocin administration will be postponed until after cord clamping if there are no obstetric concerns. At any time, the attending neonatologist and obstetrician can decide that PBCC should not be performed or be interrupted. In that case, the infant can be placed on the standard resuscitation table for (further) stabilisation. |
See 'Arm' |
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无干预：Immediate cord clamping
In the immediate cord clamping group, the cord will be clamped immediately after birth. The infant will then be transferred to the standard neonatal resuscitation table. After cord clamping, all infants will be managed according to the standardised neonatal management protocol for infants with a CDH, which is a consensus of current clinical guidelines by the CDH EURO consortium. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
大体时间：First 24 hours after birth
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Pulmonary hypertension is present if at least 2 of the following 4 criteria are present or if the infant requires extracorporeal membrane oxygenation (ECMO) in the first 24 hours after birth:
The following echocardiographic parameters will be collected to objectify these criteria:
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First 24 hours after birth
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Neonatal: mortality before discharge from the tertiary care hospital
大体时间：From birth till discharge from the tertiary care hospital, through study completion an average of one year
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Number of patients that died before discharge |
From birth till discharge from the tertiary care hospital, through study completion an average of one year
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Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
大体时间：The first 24 hours after delivery
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Number of patients with 3 or more criteria or ECMO |
The first 24 hours after delivery
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Neonatal: number of patients requiring ECMO therapy
大体时间：From admission to the ICU until the date of death or the date of discharge home, whichever came first
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Number of patients requiring ECMO therapy |
From admission to the ICU until the date of death or the date of discharge home, whichever came first
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Neonatal: number of days of duration of supplemental oxygen need
大体时间：From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Number of days of duration of supplemental oxygen need |
From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Neonatal: number of days of duration of mechanical ventilation
大体时间：From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Number of days of duration of mechanical ventilation |
From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Neonatal: duration of admission to the tertiary care hospital
大体时间：From admission to the ICU until the date of discharge to another ward or home, whichever came first
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Number of days of admission to the tertiary care hospital |
From admission to the ICU until the date of discharge to another ward or home, whichever came first
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Maternal: number of patients with postpartum haemorrhage
大体时间：The first 24 hours after delivery
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Postpartum haemorrhage is defined as estimated blood loss >1000 mL |
The first 24 hours after delivery
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合作者和调查者
出版物和有用的链接
一般刊物
- Horn-Oudshoorn EJJ, Knol R, Vermeulen MJ, Te Pas AB, Hooper SB, Cochius-den Otter SCM, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Reiss IKM, DeKoninck PLJ. Physiological-based cord clamping versus immediate cord clamping for infants born with a congenital diaphragmatic hernia (PinC): study protocol for a multicentre, randomised controlled trial. BMJ Open. 2022 Mar 18;12(3):e054808. doi: 10.1136/bmjopen-2021-054808.
- Horn-Oudshoorn EJJ, Vermeulen MJ, Knol R, Bout-Rebel R, Te Pas AB, Hooper SB, Otter SCMC, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Capolupo I, Burgos CM, Hansen BE, Reiss IKM, DeKoninck PLJ. Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan. Trials. 2024 Mar 20;25(1):198. doi: 10.1186/s13063-024-08027-7.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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