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临床试验/ACTRN12618000621213
ACTRN12618000621213已完成未知

Resuscitation of term and near-term infants with the umbilical cord intact for improving physiological transition at birth- a randomised trial.

The Royal Women's Hospital0 个研究点目标入组 123 人开始时间: 2018年4月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
123

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
Hours 至 o limit(—)
性别
All

入选标准

  • Infants greater than or equal to 32 weeks’ gestation, with a request for a paediatrician to attend the delivery for potential newborn distress, born at the participating centres, are eligible for inclusion. The intervention arm (Baby-DUCC) requires that maternal oxytocin administration will occur at between 2 and 5 minutes after delivery. Assessment of the need for early maternal oxytocin administration after delivery, and permission from the maternal care team prior to recruitment and enrolment is required.

排除标准

  • We will not approach expecting mothers of monochorionic twins and multiples of >2, fetuses with known congenital anomalies compromising cardiorespiratory transition after birth, including congenital diaphragmatic hernia, hydrops fetalis, cyanotic congenital heart defects, and airway anomalies that may compromise the ability to provide face mask PPV.
  • If the maternal treatment team feels that the mother is at high risk for obstetric complications that may be exacerbated by the study intervention, and/or requires early oxytocin administration after delivery, they will not be approached for consent. Potential maternal obstetric complications that may meet criteria for exclusion from the study at the discretion of the maternal care team include abnormal placentation, suspected placental abruption, suspected uterine rupture, significant blood loss, and coagulopathy.

研究者

发起方
The Royal Women's Hospital

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