Trial Synopsis & Study Schema
|Trial Title||Positive End-Expiratory Pressure (PEEP) Levels during Resuscitation of Preterm Infants at Birth (The POLAR Trial).|
|Objectives||This trial aims to establish whether the use of a high, dynamic PEEP strategy to support the lung during stabilisation at birth, compared with a static, standard PEEP strategy, increases the rate of survival without bronchopulmonary dysplasia (BPD) in extremely preterm infants born <29 weeks post-menstrual age (PMA).|
|Trial Design||A phase III/IV, international multicentre prospective randomised control trial to be conducted in the delivery rooms (DRs) of tertiary NICUs experienced in respiratory trials across Australian, European, British, and North American neonatal networks.|
The primary outcome is the composite outcome of wither death or BPD at 36 weeks Post-Menstrual Age (PMA), as assessed by standard oxygen reduction test.
The secondary outcomes include important short-term respiratory morbidity and potential harm outcomes in the DR and NICU. Principal secondary outcomes include:
|Trial Population||Preterm infants born between 23 weeks and 0 days and 28 weeks and 6 days PMA (post menstrual age) by best obstetric estimate who are born in participating study centres and require respiratory intervention from birth.|
Dynamic PEEP Group: Respiratory support with a dynamic PEEP algorithm (8-12 cmH2O) individualised to clinical need.
Static PEEP Group: Respiratory support with a static PEEP (5-6 cmH2O) consistent with current Neonatal Resuscitation Program (NRP) guidelines.
|Number of Participants||906 infants (453 infants per group)|
|Recruitment Period||Approximately 5 years after first infant randomised|
|Follow Up Period||24 months|
Clinicaltrials.gov Registry No: NCT04372953
ANZCTR Registry No: ACTRN12618001686291