RecruitingPHASE3INTERVENTIONAL

Doxapram Therapy in Preterm Infants (DOXA Trial)

Premature babies often have a problem called 'apnoea', where they stop breathing for short periods because their lungs aren't fully developed. This can lead to low oxygen and a slow heart rate, which might affect their brain development. While current treatments like caffeine and breathing support help, some babies still need strong breathing machines, which can cause other issues like lung problems. This study is testing if a medicine called doxapram, which stimulates breathing, can help these babies. It's thought that doxapram might reduce the need for strong breathing machines and prevent short-term oxygen problems. The study compares doxapram to a dummy medicine to see if it improves the babies' health in the long run, including their brain development and physical abilities at two years of age.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Erasmus Medical Center

Enrolment target

396

Start

15 Jun 2020

Estimated completion

01 May 2034

Apnea of Prematurity Respiratory Insufficiency

What is this study about?

When babies are born very early, their bodies, especially their lungs and brain, aren't fully ready. This can lead to a condition called 'apnoea of prematurity', where they stop breathing for a few seconds. If this happens often, their oxygen levels can drop and their heart rate can slow down, which could potentially harm their development, especially their brain.

Currently, doctors help these babies with gentle breathing support and medicines like caffeine. However, sometimes these treatments aren't enough, and babies might need a breathing machine that goes into their windpipe. While these machines can help them breathe, they can also increase the risk of long-term lung problems and affect how the baby's brain develops. Because of this, doctors try to avoid using these strong breathing machines if possible.

This study is looking at a medicine called doxapram. Doctors have used it before to help stimulate breathing in babies, but it hasn't been fully tested to see how well it works and if it has long-term benefits. We want to find out if doxapram, when given with other treatments, can help premature babies breathe better, need less intensive breathing support, and ultimately improve their overall development and health as they grow up. The main aim is to see if doxapram can help babies avoid serious problems like death, significant disability, or difficulties with brain development by the time they are two years old.

Key takeaways

Study aims to improve breathing and long-term health in premature babies.
Compares doxapram to a dummy medicine (placebo).
Focuses on reducing the need for strong breathing machines.
Investigates impact on brain development and disability at two years.
Involves follow-up assessments up to 8 years of age.

Who may be eligible?

This study is looking for very premature babies who are born before 29 weeks of pregnancy. They need to be in a special care unit (NICU) at one of the hospitals taking part in the study. Before joining, both parents or legal guardians must give their written permission.

To be considered for the study, babies must already be receiving treatment with caffeine and gentle breathing support through their nose (like CPAP). They also need to be experiencing apnoea, which means they are stopping breathing and a doctor thinks they need extra help.

However, some babies can't join the study. This includes those who have already been given doxapram before in a non-study setting, or are taking a similar medicine called theophylline. Babies with certain genetic conditions (like Down's syndrome) or serious birth defects that affect their lungs or brain, or those receiving palliative care, won'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 your baby born before 29 weeks of pregnancy?
Is your baby currently in a special care unit (NICU) in Holland or Belgium?
Is your baby already taking caffeine and using gentle breathing support?
Does your baby often stop breathing and need medical help for it?
Has your baby NOT had doxapram before, or is NOT taking theophylline?
Does your baby NOT have certain serious genetic conditions or birth defects?

Answer every question to see your result.

What does participation involve?

If your baby joins the study, they will be randomly assigned to receive either doxapram or a dummy medicine (placebo, which is a sugar solution). Neither you nor the doctors will know which one your baby is getting. The medicine will be given continuously into your baby's vein. Doctors will adjust or stop the medicine based on your baby's condition. If your baby needs a breathing tube, the study medicine will be paused and can be restarted once the tube is removed. If your baby no longer needs medicine through a vein for other reasons, the study medicine can sometimes be given through a feeding tube.

Apart from getting the study medicine, there won't be any other extra treatments or procedures just for the study. All the information about your baby's health and development will be collected as part of their usual care. For some babies, a very small amount of blood (less than half a teaspoon) will be taken when they are already having blood tests for routine care, to check the levels of doxapram in their system. The study involves long-term follow-up of your child's development at 2, 5.5, and 8 years of age, which is part of standard care for premature babies.

Potential risks and benefits

Participating in this study might offer a potential benefit if doxapram helps your baby breathe better and reduces the risk of needing strong breathing machines and related problems. However, it's also possible that doxapram might not work for your baby or could have side effects, which are carefully monitored. The dummy medicine (placebo) has no active drug and therefore no drug-related side effects. You are free to withdraw your consent for your baby to participate at any time, for any reason, without it affecting your baby's medical care.

Locations (24)

St Luc Louvain
Verified postcode
Brussels, Belgium· Recruiting
Delta Hospital Brussels
Verified postcode
Brussels, Belgium· Recruiting
University Hospital Brussels
Verified postcode
Jette, Belgium· Recruiting
Grand Hospital de Charleroi
Verified postcode
Charleroi, Belgium· Recruiting
Clinique Saint-Vincent Liege
Verified postcode
Liège, Belgium· Suspended
Academisch Ziekenhuis Sint-Jan
Verified postcode
Bruges, Belgium· Recruiting
Sint Augustinus Hospital Antwerp
Verified postcode
Antwerp, Belgium· Recruiting
University Hospital Antwerp
Verified postcode
Antwerp, Belgium· Recruiting
Chirec-Delta Hospital
Verified postcode
Brussels, Belgium· Recruiting
University Hospitals Leuven
Verified postcode
Leuven, Belgium· Recruiting
Foothills Medical Centre
Verified postcode
Calgary, Canada· Not yet recruiting
Royal Alexandra Hospital
Verified postcode
Edmonton, Canada· Not yet recruiting

Common questions

What is apnoea of prematurity?

It's when premature babies briefly stop breathing because their lungs and brain aren't fully developed yet.

What is doxapram?

Doxapram is a medicine that helps stimulate breathing. We're studying if it can help premature babies breathe better and prevent long-term problems.

Will my baby get real medicine or a dummy medicine?

Your baby will be randomly assigned to receive either doxapram or a dummy medicine (placebo). Neither you nor the medical team will know which one it is.

How long will the study follow my baby?

The study will follow your child's development up to 8 years of age, which is often part of standard care for premature babies.

Can I remove my baby from the study if I change my mind?

Yes, you can withdraw your baby from the study at any time without it affecting their medical care.

How to find out more

Sinno HP Simons, MD, PhD

s.simons@erasmusmc.nl +31641376695 Official trial record

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