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 multi-centre 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.
Trial Outcomes

The primary outcome is the composite outcome of either 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:

  • Failure on non-invasive ventilation in the first 72 hours
  • Oxygen requirement ≥50% for 3 or more consecutive hours in the first 72 hours
  • Surfactant therapy in the first 72 hours
  • Air leak and/or pulmonary interstitial emphysema in the first 10 days of life
  • Patent ductus arteriosus requiring therapy
  • Grade 3 or 4 intraventricular haemorrhage (on ultrasound)
  • Intubation in the delivery room
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.
Trial Intervention

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
Trial Registration

Clinicaltrials.gov Registry No:  NCT04372953

ANZCTR Registry No:  ACTRN12618001686291

 

Study Schema

 

 

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