Positive End-Expiratory Pressure (PEEP) Levels during Resuscitation of Preterm Infants at Birth (The POLAR Trial).

Phase 3

Recruiting

• Conditions: Preterm Birth; Reproductive Health and Childbirth - Complications of newborn; Respiratory Distress Syndrome; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12618001686291
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-12
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 906

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is death or Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA, as assessed using the Modified Walsh definition and standard oxygen reduction test.[36 weeks Post Menstrual Age (PMA).]