RecruitingPhase 3Phase 4ACTRN12618001686291

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?


Sponsor

Murdoch Children's Research Institute

Enrollment

906 participants

Start Date

May 19, 2021

Study Type

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

Sex: Both males and femalesMin Age: 0 HourssMax Age: 0 Hourss

Plain Language Summary

Simplified for easier understanding

Extremely premature babies — born between 23 and 28 weeks of pregnancy — need immediate breathing support at birth because their lungs are far too immature to breathe on their own. One of the first tools doctors use is CPAP (Continuous Positive Airway Pressure), which delivers a continuous gentle pressure through a mask to help keep tiny airways open. The right amount of this pressure — not too little to be ineffective, not too much to cause harm — is not yet well established. Current guidelines suggest using a CPAP pressure of 5 to 6 centimetres of water, but growing evidence suggests that higher pressures (8 to 10 cm) may be more effective immediately after birth when the lungs are at their most collapsed. The POLAR Trial randomly assigns very preterm babies to either the standard pressure or a higher, individualised pressure strategy, and measures which approach leads to better survival without serious lung complications and less need for full mechanical ventilation in the first three days of life. This trial involves babies born between 23 weeks and 28 weeks and 6 days who need respiratory support at birth. Babies with major congenital abnormalities, known lung conditions such as severe pulmonary hypoplasia, or whose families have chosen palliative rather than intensive care are not eligible. The study takes place in neonatal intensive care units across multiple hospitals and involves no extra procedures beyond standard resuscitation care.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(11)

The Royal Women's Hospital - Parkville

VIC, Australia

King Edward Memorial Hospital - Subiaco

VIC, Australia

Mater Mother's Hospital - South Brisbane

VIC, Australia

Womens and Childrens Hospital - North Adelaide

VIC, Australia

Amsterdam, Netherlands

PH, AK, CA, United States of America

Feldkirch, Austria

England and Scotland, United Kingdom

Paris, France

Milan, Florence and Rome, Italy

Poznan, Poland

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