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

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Apr 29, 2020

Keywords

ClinConnect Summary

The POLAR Trial is studying how to best help premature babies breathe right after they are born. Premature infants often need assistance to open their lungs and start breathing because their lungs are not fully developed. A common treatment used is called positive end-expiratory pressure, or PEEP, which keeps the lungs open by delivering air between breaths. This trial will compare two different methods of providing PEEP: one that uses the same level throughout, and another that starts with a higher level at birth and then decreases it as the baby begins to breathe better. The goal is to see if one method can reduce the amount of breathing support these babies need in the long run.

To participate in the trial, babies must be born very prematurely, between 23 and 28 weeks of gestation, and require help with breathing right after birth. The study is open to all genders, and parents or guardians will need to provide consent for their participation. By taking part in this research, families can contribute to finding better ways to support the health of premature infants and potentially lower their risk of long-term lung problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants born between 23 weeks 0 days and 28 weeks 6 days PMA (by best obstetric estimate).
• • Receives respiratory intervention (resuscitation) at birth with CPAP and/or positive pressure ventilation in the Delivery Room, to support transition and/or respiratory failure related to prematurity.
• • 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:
• • Not for active care based on assessment of the attending clinician or family decision
• • Anticipated severe pulmonary hypoplasia due to rupture of membranes \<22 weeks with anhydramnios or fetal hydrops
• • Major congenital anomaly or anticipated alternative cause for respiratory failure
• • Refusal of informed consent by their legally acceptable representative
• • Does not have a guardian who can provide informed consent.