RecruitingNAINTERVENTIONAL

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants

Many premature babies need some help with their breathing for a while. Usually, a breathing machine called NCPAP is used, which is effective but can be tricky and sometimes has side effects. This study is investigating another type of breathing support, called NHF (nasal high flow therapy). Researchers want to find out if NHF is just as effective as NCPAP for premature babies who are already breathing quite steadily. They believe NHF might be easier to use and more comfortable for the babies. The aim is to see if NHF can provide similar breathing stability to NCPAP, and whether it makes babies more comfortable, which could lead to it being used more widely.

At a glance

Status

Recruiting

Phase

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

150

Start

01 Jul 2023

Estimated completion

01 Feb 2026

Respiratory Distress Syndrome

What is this study about?

When babies are born early, their lungs aren't fully developed, so they often need help with their breathing. One common way to provide this support is called NCPAP, which stands for nasal continuous positive airway pressure. It's like having a gentle puff of air through little tubes in the nose that keeps the airways open. NCPAP is known to be very good at helping babies breathe, but it can sometimes be uncomfortable and needs careful management.

Now, there's another method called NHF, or nasal high flow therapy. The difference is mainly in how the air is delivered – NHF generally uses a different type of gentle airflow. Doctors are keen to find simpler and more comfortable ways to support premature babies, especially those who are already breathing fairly well on their own but still need a little extra help. This study aims to see if NHF can keep babies' breathing stable just as effectively as the traditional NCPAP treatment.

Ultimately, if NHF proves to be just as effective and more comfortable for these babies, it could become a more widely used option in hospitals. This could mean a better experience for the babies and potentially make things a bit simpler for the healthcare team looking after them. The study is particularly interested in how stable a baby's heart rate and breathing are while using these different supports.

Key takeaways

Compares two breathing supports (NCPAP and NHF) for premature babies.
Aims to find out if NHF is as effective and more comfortable than NCPAP.
Involves babies already breathing fairly well on their own (stable).
Focuses on how stable baby's breathing and heart rate are.
Participation involves careful observation using standard hospital monitoring.
Could lead to a more comfortable breathing support option for premature babies.
You can withdraw your baby from the study at any time.

Who may be eligible?

This study is looking for premature babies who were born between 23 and 31 weeks gestation. To join, a baby must be at least two days old and admitted to specific hospitals in Switzerland or Germany. Importantly, babies should already be quite stable on the NCPAP breathing support for at least 24 hours before joining the study.

Being stable means their breathing rate is steady, they're not having too many pauses in breathing or drops in heart rate, and they don't need too much extra oxygen. Also, their parents or legal guardians must be at least 18 years old and agree in writing for their baby to take part.

Babies can't join if they have significant serious health problems from birth, if they're receiving end-of-life care, or if they've been stable on NCPAP for a very long time (more than 120 hours).

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 23 and 31 weeks of pregnancy?
Is your baby at least two days old?
Has your baby been breathing fairly well, without needing lots of extra help, for at least 24 hours on NCPAP?
Does your baby not have any major জন্মগত (birth) problems or health issues that would prevent study participation?
Are you, as the parent or legal guardian, 18 years or older and willing to give written permission?

Answer every question to see your result.

What does participation involve?

If your baby takes part, they will be randomly assigned to receive one of three types of breathing support: either a higher flow NHF, a lower flow NHF, or the standard NCPAP. This is like flipping a coin to decide, so it's fair. The breathing support will be set up by the hospital staff, just as they normally would. The study will mainly involve careful observation of your baby's breathing and heart rate to see how stable they are on the assigned support. This will be done through the usual monitoring equipment already in place in the intensive care unit. The total time your baby would be involved in the study's specific observations would depend on how long they need breathing support but focuses on the initial period after starting one of the study treatments. There are no extra hospital visits required beyond your baby's ongoing care.

Potential risks and benefits

Participating in this study might offer your baby the potential benefit of receiving a type of breathing support (NHF) that some believe to be more comfortable, while aiming to provide the same level of stability as standard care. The risks involved are generally low, as both NCPAP and NHF are established methods of breathing support. However, as with any medical treatment, there's always a small chance of unexpected side effects, which the medical team will monitor closely. You are free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (2)

University Medical Center of the Johannes Gutenberg-University Mainz
Verified postcode
Mainz, Germany· Recruiting
Department of Pediatrics, Inselspital
Verified postcode
Bern, Switzerland· Recruiting

Common questions

What is cardiorespiratory stability?

It means how steady your baby's heart rate and breathing are. The study wants to see which breathing support helps keep them most stable.

What is `NHF` exactly?

NHF stands for Nasal High Flow. It's a way of giving gentle, warm, humidified air and oxygen through small tubes placed in your baby's nose, similar to NCPAP but often considered less intrusive.

Will my baby get extra medication as part of the study?

No, this study is about comparing different ways to provide breathing support, not about new medications. Your baby will only receive standard medical care and any necessary medicines as decided by their doctors.

Can I still hold my baby if they are on one of these breathing supports?

Yes, the medical team will do their best to support skin-to-skin contact and other forms of bonding as much as your baby's condition allows, regardless of the breathing support they are receiving.

Who is paying for this study?

The information provided does not specify the funding source for this particular study.

How to find out more

Lisa Marie Bünte

lisamarie.buente@insel.ch +41 31 632 19 23 Official trial record

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