RecruitingNAINTERVENTIONAL

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

This study is for very tiny babies born too early, whose lungs and breathing muscles aren't fully grown. They often need help to breathe using machines like CPAP or NIPPV, which give gentle air pressure through their nose. CPAP gives constant pressure, while NIPPV adds extra puffs of air. Doctors usually use NIPPV if CPAP isn't enough, trying to avoid more intensive breathing machines. This study compares how these methods affect a baby's main breathing muscle, the diaphragm. We measure a special signal (Edi) from a feeding tube to see how hard the diaphragm is working. We aim to understand which method supports their breathing muscles best, which could help improve care for these fragile babies.

At a glance

Status

Recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

21 Aug 2021

Estimated completion

31 Dec 2026

Preterm Birth Premature Lungs Respiratory Distress Syndrome in Premature Infant

What is this study about?

When babies are born very early, their bodies, including their lungs and breathing muscles, aren't fully ready to work on their own. This means they often need help to breathe. Two common ways doctors support their breathing are with CPAP (Continuous Positive Airway Pressure) and NIPPV (Non-Invasive Positive Pressure Ventilation). Both methods deliver gentle air pressure through a mask or prongs placed on the baby's nose, helping to keep their tiny air sacs open and making breathing easier.

CPAP provides a steady, continuous stream of air pressure. Think of it like gently inflating a balloon and keeping it inflated so it doesn't collapse. NIPPV does this too, but it also adds extra, gentle puffs of air at regular times. Doctors often choose NIPPV if CPAP isn't quite enough, hoping to prevent the baby from needing a more invasive breathing tube. There's also a newer idea of using 'high CPAP' – a stronger but still continuous pressure.

This study wants to find out which of these breathing methods (traditional CPAP, NIPPV, or high CPAP) best helps a baby's main breathing muscle, called the diaphragm. We measure a special signal, called the Edi signal, which tells us how hard the diaphragm is working. This is done using a special feeding tube that has tiny sensors. This tube is safe and helps us understand how the different breathing supports affect the baby's own breathing efforts. Ultimately, understanding this better could help doctors choose the best breathing support for each tiny, premature baby.

Key takeaways

Studies which breathing support works best for premature babies' diaphragm.
Compares standard CPAP, NIPPV, and a higher level of CPAP.
Uses a special feeding tube to measure breathing muscle activity.
Study period for your baby is 6 hours.
Aims to improve breathing care for very tiny newborns.

Who may be eligible?

This study is looking for very tiny babies born weighing less than 1,500 grams (about 3 pounds, 5 ounces) who are already receiving gentle breathing support with CPAP. To join, babies need to be generally stable, meaning their heart rate and blood pressure are steady, and they haven't had a recent increase in breathing pauses.

However, some babies can't take part. This includes those with certain birth defects, problems with their diaphragm or nerves that control breathing, specific heart conditions, or serious brain bleeds. Babies who are currently being treated for serious infections or stomach problems, or who have certain facial differences or lung collapses, would also not be able to join.

This is to make sure the study is as safe as possible for all participating babies and that we get clear results about the breathing supports.

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 your baby a premature infant?
Does your baby weigh less than 1500 grams (about 3 lbs 5 oz)?
Is your baby currently receiving CPAP for breathing support?
Is your baby generally stable with steady heart rate and blood pressure?
Does your baby require less than 35% oxygen while on CPAP?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree to take part, their usual feeding tube will be replaced with a special one that also has sensors to measure their breathing muscle activity (Edi signal). This tube will still be used for feeding. Over a total of 6 hours, your baby will try three different types of breathing support: traditional CPAP, NIPPV, and a higher level of CPAP. Each method will be used for two hours, and the Edi signal will be recorded during this time. After the 6 hours, your baby will go back to whatever breathing support they were on before the study. Throughout the study, nurses will continue to monitor your baby's oxygen levels and heart rate, as they normally would.

Potential risks and benefits

We hope this study will help us learn which breathing support method works best for the breathing muscles of very tiny premature babies, potentially leading to better care in the future. The risks of taking part are very small, as the special tube used is similar to the normal feeding tube, and the breathing supports are routine for these babies. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their care.

Locations (1)

Sunnybrook Health Sciences Center
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is CPAP?

CPAP is a common way to help premature babies breathe by delivering a gentle, steady stream of air pressure through their nose to keep their tiny lungs open.

What is NIPPV?

NIPPV is similar to CPAP but also gives extra, regular puffs of air pressure to help babies breathe, often used when CPAP alone is not enough.

What is an Edi signal?

The Edi signal measures how active your baby's main breathing muscle, the diaphragm, is. It helps doctors understand how well your baby is breathing with support.

How long does the study last?

The study part involving your baby's breathing support only lasts for 6 hours in total.

Will my baby still be fed during the study?

Yes, the special tube used to measure breathing will also be used for your baby's regular feedings.

How to find out more

Maher Shahroor, MD

maher.shahroor@sunnybrook.ca (416) 480-6100 Official trial record

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