RecruitingNAINTERVENTIONAL

PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY

This study is for babies born very early, before 32 weeks, who often have underdeveloped lungs. Their lungs can sometimes deflate between breaths. Doctors use gentle pressure, called PEEP or CPAP, to keep their airways open. The right amount of pressure can prevent lung damage and help babies breathe more comfortably. Currently, there’s no clear agreement on the best pressure level. This study uses a new, radiation-free scanning method called Electrical Impedance Tomography (EIT) to continuously monitor how different pressure levels (from 4 to 10 cm H2O) affect the babies' lungs. The goal is to find the most effective pressure to keep their lungs open and healthy, whether they are on a breathing machine or CPAP.

At a glance

Status

Recruiting

Phase

Sponsor

South Tees Hospitals NHS Foundation Trust

Enrolment target

Start

15 Jun 2025

Estimated completion

31 Dec 2026

PreTerm Neonate Positive End Expiratory Pressure (PEEP)Lung Recruitment Electrical Impedance Tomography (EIT)

What is this study about?

When babies are born very early, typically before 32 weeks, their tiny lungs haven't had enough time to grow strong. This means their lungs might struggle to stay open after each breath, sometimes collapsing a little. To help with this, doctors provide gentle support using something called PEEP or CPAP. Think of it like giving a little puff of air that helps to keep the tiny air sacs in their lungs from shutting down completely. This makes it easier for oxygen to get into their bodies and can make breathing more comfortable for the baby.

Finding just the right amount of this gentle pressure is really important. If the pressure isn't quite right – either too low or potentially too high – it could lead to problems with their lungs. In fact, if babies born early need a breathing machine for a long time, it can sometimes cause further lung injury. At the moment, different hospitals use different pressure levels because we don't have enough clear information to say what the absolute best level is for these very premature babies.

This study is trying to find that 'sweet spot' for pressure. We're using a special, safe scanning method called Electrical Impedance Tomography (EIT). Imagine it like a continuous, incredibly detailed look at how your baby’s lungs are working, but without any X-rays or radiation. This new technology helps us see how different levels of gentle pressure affect the baby’s lungs in real-time. By trying out different pressure settings (from 4 to 10 cm H2O) and watching the lungs closely with EIT, we hope to discover the ideal pressure that keeps their lungs open, healthy, and developing as well as possible. This could lead to better care for many other premature babies in the future.

Key takeaways

Targets premature babies (under 32 weeks) with immature lungs.
Investigates the best level of gentle breathing pressure (PEEP/CPAP) to keep tiny lungs open.
Uses a new, radiation-free scan (EIT) to see lung responses in real-time.
Aims to reduce lung damage and improve breathing for premature babies.
Adjustments to pressure are within normal clinical ranges.
Participation is safe and does not alter routine medical care.

Who may be eligible?

This study is looking for tiny babies who were born very early, specifically between 22 and 32 weeks of pregnancy. They should be within their first two weeks of life and currently receiving help with their breathing, either through a CPAP machine or a breathing machine (ventilator).

For a baby to join, one of their parents needs to give their written permission. We're focusing on babies in their first two weeks because after that, their lungs might have already experienced some changes that would make it harder to understand the results of this study properly. Also, this timeframe allows parents a little time to adjust after a stressful early birth before we approach them about the study.

However, some babies cannot take part. This includes babies who have major birth defects, especially those affecting their lungs or heart. Babies who have a collapsed lung (called a pneumothorax) or those on a very specific type of breathing machine called 'high frequency ventilation' also can't join. Finally, if a baby has very delicate skin that might be irritated by the equipment, they wouldn't be able to participate.

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.

Was my baby born before 32 weeks of pregnancy?
Is my baby currently receiving breathing support (CPAP or a breathing machine)?
Is my baby within their first two weeks of life?
Does my baby have any major birth defects affecting their lungs or heart?
Has my baby had a collapsed lung?
Does my baby have very sensitive skin that could be easily irritated?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will continue to receive the breathing support they already need (either CPAP or a breathing machine). Doctors will carefully adjust the gentle pressure levels (PEEP/CPAP) during a short period, moving between levels of 4 to 10 cm H2O. Throughout this time, a special belt with small sensors, like sticky pads, will be placed around your baby's chest. This is the EIT machine, which will safely and continuously monitor how your baby's lungs respond to these different pressure levels. It's like getting a constant, detailed picture of their lung activity, but without any X-rays or radiation. All other medical care for your baby will continue as normal. There are no extra hospital visits required, as all monitoring will happen at the bedside. The duration of the study measurements for your baby will be short, typically lasting only a few hours during one session while they are already in the neonatal unit.

Potential risks and benefits

Participating in this study might help us understand the best way to support the delicate lungs of premature babies, potentially leading to improved care for many babies in the future. For your baby, the main activity is the safe use of a chest belt with sensors to monitor their lungs, which is non-invasive and does not use radiation. There's a very small chance your baby might experience minor skin irritation from the sensor pads, but these are designed to be gentle for delicate skin. We will be adjusting pressure levels within a range that is already common practice in neonatal units, so your baby will still receive good standard care. You are completely free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

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

South Tees NHS Trust
Verified postcode
Middlesbrough, United Kingdom· Recruiting

Common questions

What is PEEP/CPAP?

PEEP stands for Positive End-Expiratory Pressure, and CPAP stands for Continuous Positive Airway Pressure. Both involve applying a gentle, constant air pressure to a baby's airways to help keep their tiny lung air sacs open and prevent them from collapsing between breaths.

What is Electrical Impedance Tomography (EIT)?

EIT is a new way to look at how the lungs are working. It uses small, sticky pads on the chest to send tiny electrical currents and then measures how they pass through the body. This creates a detailed, live picture of what's happening inside the lungs without using any X-rays or radiation, so it's very safe for babies.

Will this study change my baby's usual care?

No, your baby will continue to receive all the care they need. This study simply involves carefully and briefly adjusting the gentle pressure levels within a safe range, while using the EIT monitor to see the effects. All other medical treatments will stay the same.

Are there any side effects for my baby?

The EIT monitoring is non-invasive and doesn't use radiation. The only potential side effect is very minor skin redness or irritation from the sticky pads, which is rare and usually goes away quickly after they are removed. The pressure levels used are within typical clinical practice.

What if I decide I don't want my baby to be in the study anymore?

You are free to withdraw your baby from the study at any time, for any reason. This decision will not affect the medical care your baby receives in any way.

How to find out more

Prakash Kannan Loganathan, MD

pkannanloganathan@nhs.net +447481492632 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.