Does the use of a high, dynamic, positive end-expiratory pressure strategy to support the lung during stabilisation at birth, compared with a standard, static PEEP, reduce the rate of death or bronchopulmonary dysplasia (BPD); and/or the rate of failure of non-invasive respiratory support in the first 72 hours after birth?

Murdoch Children's Research Institute0 个研究点目标入组 906 人开始时间: 2018年10月12日最近更新: 2023年2月13日

适应症

试验速览

暂无简介。

•Each infant must meet all of the following criteria to be enrolled in this study:
•1. Born between 23 weeks 0 days and 28 weeks 6 days PMA (by best obstetric estimate)
•2. Receives respiratory intervention (resuscitation) at birth with CPAP and/or positive pressure ventilation in the DR to support transition and/or respiratory failure related to prematurity
•3. Has a parent or other legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf either prospectively or after birth and randomisation if prenatal consent was not possible (at sites where the Ethics Committee permits waiver of prospective consent).

•Infants meeting any of the following criteria will be excluded from the study:
•1. Not for active care based on assessment of the attending clinician or family decision
•2. Anticipated severe pulmonary hypoplasia due to rupture of membranes <22 weeks’ with anhydramnios or fetal hydrops
•3. Major congenital anomaly or anticipated alternative cause for respiratory failure
•4. Refusal of informed consent by their legally acceptable representative
•5. Does not have a guardian who can provide informed consent.

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