Active not recruitingNAINTERVENTIONAL

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

This study, called 'The POLAR Trial', investigates how best to use a breathing support called Positive End-Expiratory Pressure (PEEP) for very premature babies. PEEP helps keep their tiny, underdeveloped lungs open and prevents them from collapsing between breaths. Doctors currently use different PEEP levels because there isn't enough evidence to say which is best. This trial compares two approaches: giving a steady PEEP level or starting with a higher PEEP to help open the lungs, then lowering it. The aim is to find out if one method leads to babies needing less breathing support, which could reduce their risk of long-term lung disease. Researchers from Australia, the Netherlands, and the USA are leading this important work.

At a glance

Status

Active not recruiting

Phase

Sponsor

Murdoch Childrens Research Institute

Enrolment target

906

Start

04 May 2021

Estimated completion

30 May 2028

Lung Injury Preterm Birth

What is this study about?

When babies are born very prematurely, their lungs aren't fully developed. This can make it very hard for them to take their first breaths and keep their lungs open. To help with this, nearly all premature babies receive a type of breathing support that includes something called Positive End-Expiratory Pressure, or PEEP. Think of PEEP like a gentle puff of air that's given between each breath to keep the tiny air sacs in the lungs from completely closing down. This helps make breathing easier for the baby.

At the moment, doctors around the world use different amounts of PEEP because we don't know for sure which level is most effective and safest. This study, called 'The POLAR Trial', wants to find the answer. It will look at two main ways of giving PEEP to premature babies right after they're born. One way is to give a constant, steady amount of PEEP. The other way is to start with a slightly higher PEEP level when the lungs are hardest to open, and then gradually reduce it once the lungs are more established and the baby is breathing better. Researchers don't yet know if one method is better than the other.

This research is really important because very premature babies are at risk of developing long-term lung problems. The more breathing support a baby needs, the higher this risk can be. By finding the best way to open a baby's lungs at birth, the doctors hope to reduce the overall amount of breathing support needed, and in turn, potentially lower the chances of these long-term lung issues. This study is being led by a group of doctors who specialise in looking after premature babies from different countries.

Key takeaways

This study compares two different ways of giving breathing support (PEEP) to premature babies.
The goal is to find the best PEEP approach to help open tiny lungs at birth.
It aims to reduce the amount of breathing support babies need, potentially lowering long-term lung problems.
No new medicines or extra tests are involved beyond standard care.
Participation helps future premature babies, and you can withdraw at any time.

Who may be eligible?

This study is looking for very premature babies whose parents or guardians agree for them to take part. This includes babies born between 23 weeks and 28 weeks and 6 days of pregnancy.

Babies can join if they need help with their breathing, such as CPAP (continuous positive airway pressure) or other forms of breathing support, right after they are born. Crucially, a parent or legal guardian must be able to understand the study information and give their permission for the baby to participate.

However, some babies might sadly not be able to take part. This includes babies who are not receiving active care, those with severe lung underdevelopment (from certain complications during pregnancy), or babies with other major health problems that could affect their breathing. If a parent or guardian does not wish for their baby to take part, or if there is no guardian to give permission, the baby cannot be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my baby born very prematurely (between 23 and 28 weeks 6 days of pregnancy)?
Does my baby need breathing support (like CPAP) right after birth?
Am I, or another legal guardian, able to understand information about the study and give permission?
Has my baby's doctor not said that active medical care is unsuitable?
Does my baby not have severe lung problems or other major health issues that would rule them out?

Answer every question to see your result.

What does participation involve?

This is a clinical trial, which means babies taking part will be randomly assigned to receive one of the two PEEP approaches mentioned: either a constant PEEP level or a higher PEEP level that is then reduced. This will happen during their initial breathing support right after birth. Besides the type of PEEP they receive, the babies will otherwise receive the standard care and monitoring that all premature babies in the hospital get. There are no extra hospital visits or special medication involved beyond what is normally given for premature babies. Doctors will carefully monitor their breathing and overall health, just as they would for any baby born prematurely. The study will track how much breathing support the baby needs over time and their general health outcomes, particularly focusing on their lung health in the long term.

Potential risks and benefits

Taking part in this study may or may not directly benefit your baby, as we don't yet know which PEEP approach is better. However, the information gained will help improve care for many future premature babies. There are no known extra risks associated with either PEEP approach compared to current standard treatment, as both are already used in practice. As with any clinical trial, you are free to withdraw your baby from the study at any time without it affecting their medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
Sharp Mary Birch Hospital for Women & Newborns
Verified postcode
San Diego, United States
Indiana University / Riley Children Health at Indiana University Health
Verified postcode
Indianapolis, United States
Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States
Mater Misericordiae
Verified postcode
South Brisbane, Australia
Women & Childrens Hospital Adelaide
Verified postcode
Adelaide, Australia
Joan Kirner Women & Children's Hospital - VIC
Verified postcode
Melbourne, Australia
The Royal Women's Hospital, Melbourne Australia
Verified postcode
Parkville, Australia
King Edward Memorial Hospital
Verified postcode
Subiaco, Australia
Academic Teaching Hospital
Verified postcode
Feldkirch, Austria
Antoine Beclere Medical Center / South Paris University Hospitals
Verified postcode
Paris, France
San Gerardo Hospital
Verified postcode
Monza, Italy

Common questions

What is PEEP?

PEEP stands for Positive End-Expiratory Pressure. It's a gentle puff of air given between breaths to help keep a baby's tiny lungs open and stop them collapsing.

Why is this study important for my baby?

This study aims to find the best way to help premature babies breathe, potentially reducing their need for breathing support and lowering the risk of long-term lung problems. Your baby's participation could help improve care for many future premature babies.

Will my baby get extra medicines or tests?

No, babies in this study will receive the usual care, monitoring, and medicines given to premature babies. The only difference is which of the two PEEP approaches is used at birth.

What if I change my mind about my baby participating?

You can withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Who is running this study?

The study is being led by a group of expert doctors who care for premature babies in Australia, the Netherlands, and the USA.