Positive End-Expiratory Pressure (PEEP) Levels during Resuscitation of Preterm Infants at Birth (The POLAR Trial).
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 Institute
906 participants
May 19, 2021
Interventional
Conditions
Summary
This multicentre randomised controlled trial will determine how best to apply Positive End-Expiratory Pressure (PEEP) to support the preterm lung during stabilisation (‘resuscitation’) at birth. PEEP is a proven therapy that helps preterm babies breath but what PEEP levels to use is unknown. Currently PEEP levels of 5-6 cmH2O are usually used, but increasing evidence suggests that higher PEEP levels than this are initially needed immediately after birth. We hypothesise that in preterm infants born between 23 and 28 weeks post menstrual age, a high, dynamic PEEP strategy (PEEP 8-10 cmH2O individualised to clinical need) as compared to a standard, static PEEP of 5-6 cmH2O during stabilisation at birth, will 1) increase survival without bronchopulmonary dysplasia, 2) reduce the failure of non-invasive respiratory support in the first 72 hours of life (co-primary outcomes), and 3) reduce rates of common neonatal morbidities (secondary outcomes).
Eligibility
Plain Language Summary
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Interventions
High dynamic Positive End-expiratory Pressure (PEEP): Initial PEEP delivered at 8 cmH2O via a T-Piece resuscitator in an initial fraction of inspired oxygen (FiO2) of 0.30 via local standard interface (facemask, nasopharyngeal tube or nasal prong). Increase in PEEP to 10 cmH2O (2 cmH2O increment) at 60s if infant meets pre-defined criteria for respiratory deterioration (see below). Ongoing resuscitative care at PEEP 10 cmH2O unless the infant has a heart rate >120 bpm and oxygen needs <0.30 for more than 60s in which case PEEP will be reduced to 8 cmH2O. Respiratory Deterioration is defined as a heart rate <100 beats per minute (bpm), apnoea, and/or increasing oxygen required to maintain heart rate and SpO2 targets, these criteria indicating that additional resuscitation measures need to be implemented.
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ACTRN12618001686291