RecruitingOBSERVATIONAL

Respiratory Support and Brain Health in Preterm Infants

Premature babies often need help with breathing because their lungs aren't fully developed. This study compares two types of gentle breathing support given through a mask or prongs on the nose. One is the usual method called NIPPV. The other is a newer method called NIV-NAVA. We want to find out if NIV-NAVA helps babies sleep better, improves the oxygen levels in their brain, reduces discomfort, and makes their breathing muscle stronger. We believe that by matching the baby's own breathing better, NIV-NAVA might lead to better development for these tiny babies. Doctors will check how well babies sleep, their brain oxygen, and other measures to see which method is best for their overall health and development.

At a glance

Status

Recruiting

Sponsor

Mount Sinai Hospital, Canada

Enrolment target

Start

04 Jul 2023

Estimated completion

01 Jan 2026

Sleep Cerebral Oxygenation

What is this study about?

When babies are born very early, their lungs might not be strong enough to breathe on their own. To help them, doctors use special machines that provide gentle breathing support. While a breathing tube (put down the throat) can be used, it's often better to use a mask or soft prongs on the baby's nose to give this support. This study is all about finding the very best way to support these tiny babies' breathing.

We're looking at two kinds of gentle breathing support. The first is called NIPPV, which is a common method where the machine provides breaths at a set rate. The second, newer method is called NIV-NAVA. With NIV-NAVA, a special tube helps the machine 'listen' to the baby's own breathing efforts. The machine then gives a gentle 'top-up' breath that matches the baby's own rhythm, making it feel more natural. We want to see if this more natural breathing support helps babies sleep better, keeps their brain healthier by improving oxygen levels, and makes them more comfortable. It's really important to support both lung and brain development during these early weeks.

The main goal of this study is to compare these two breathing methods. We'll be looking carefully at how well babies sleep, how much oxygen gets to their brain, and their comfort levels while they are on either NIPPV or NIV-NAVA. We hope to learn if NIV-NAVA, by working more in sync with the baby, can offer better protection for their growing brain and help them feel more at ease.

Key takeaways

The study compares two gentle breathing supports for premature babies: NIPPV and NIV-NAVA.
It aims to find out if NIV-NAVA helps babies sleep better and protects their brain more.
NIV-NAVA works by matching the baby's own breathing efforts more closely.
Doctors will monitor sleep, brain oxygen, and comfort levels in participating babies.
The goal is to improve care and long-term development for premature infants.

Who may be eligible?

This study is looking for premature babies who were born between 22 and 31 weeks and 6 days of pregnancy, and who weigh more than 500 grams (about 1.1 pounds) when doctors ask for consent. To join, your baby also needs to be at least 3 days old.

Your baby must also be stable and doing well on their current breathing support (either NIPPV or NIV-NAVA) for at least 24 hours before joining. This means their oxygen levels and blood pressure have been consistent, they don't have an active infection, and they aren't on certain heart medications.

Babies cannot join the study if they have severe bleeding in the brain (grade 3 or 4 IVH), were born with a very low weight compared to other babies at their gestation (below the 3rd percentile), or have certain genetic or birth problems.

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 your baby born between 22 and 31 weeks and 6 days of pregnancy?
Does your baby currently weigh more than 500 grams (about 1.1 pounds)?
Is your baby at least 3 days old?
Has your baby been stable on their current breathing support for at least 24 hours?
Does your baby NOT have severe brain bleeding or certain genetic conditions?

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 are already on (either NIPPV or NIV-NAVA) as part of their regular care. The study involves comparing what happens when babies are on NIPPV versus NIV-NAVA. The main difference for your baby will be that doctors will closely monitor things like their sleep patterns, how much oxygen is getting to their brain, and their heart rate, using standard hospital monitors. There are no extra medications given for the study. The total duration of participation will depend on how long your baby needs breathing support, but the study assessments will focus on specific periods while they are receiving either of the two breathing support methods.

Potential risks and benefits

Potential benefits of taking part include your baby receiving very close monitoring of their breathing, sleep, and brain oxygen levels. The information gathered may help improve care for other premature babies in the future by identifying the best type of breathing support. There are no known direct risks to your baby from the breathing support methods themselves, as NIPPV and NIV-NAVA are already part of standard care for premature babies. However, as with any study, there's always a chance of unforeseen mild discomfort from extra monitoring equipment, although all efforts are made to minimise this. Your decision to participate is completely voluntary, and you have the right to withdraw your baby from the study at any time without affecting their medical care.

Locations (1)

Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is NIPPV?

NIPPV is a common type of gentle breathing support for premature babies, given through a mask or nasal prongs. It provides breaths at a set rate and pressure.

What is NIV-NAVA?

NIV-NAVA is a newer type of gentle breathing support that 'listens' to your baby's own breathing efforts and gives a 'top-up' breath that matches their rhythm, making it more natural.

Will my baby get extra medicine?

No, your baby will not receive any extra medications as part of this study. The study focuses on comparing two types of breathing machines.

How long will my baby be in the study?

Your baby's participation depends on how long they need breathing support. The study measurements will take place during specific periods while they are on either NIPPV or NIV-NAVA.

What will happen if my baby joins?

If your baby joins, doctors will closely check things like their sleep, brain oxygen, and comfort while they are on NIPPV or NIV-NAVA, using the usual hospital monitors.

How to find out more

Poorva Deshpande

poorva.deshpande@sinaihealth.ca 416-586-4800 Official trial record

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