ACTRN12618001686291
Recruiting
Phase 3
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?
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- Murdoch Children's Research Institute
- Enrollment
- 906
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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