RecruitingOBSERVATIONAL

Post-Extubation Assessment of Clinical Stability in ELBW Infants

This study is checking if new monitoring equipment can help doctors look after extremely premature babies (those born weighing less than 1 kilogram). Many of these tiny babies need help with their breathing, and sometimes, after their breathing tube is taken out, they might need it put back in. This research uses special sensors, like those that check oxygen levels in the brain and tummy, and another that looks at how the lungs are working. By watching these things closely, along with other health information, doctors hope to get a clearer picture of how stable a baby is. This could help them make quicker, more informed decisions about a baby's breathing support, potentially leading to better care and outcomes for these vulnerable infants.

At a glance

Status

Recruiting

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

Start

29 Oct 2024

Estimated completion

01 Apr 2027

Extremely Low Birth Weight Infants

What is this study about?

This research is looking into better ways to monitor extremely premature babies, specifically those born weighing less than 1 kilogram. These babies often need help with their breathing, and after they've had a breathing tube removed, there's a chance they might need it again. This study is testing if a new system that combines different types of information can help doctors understand a baby's condition more clearly.

The system uses special sensors that are gently placed on the baby. For example, some sensors measure oxygen levels in the brain and tummy, while another looks at how well the tiny lungs are inflating and deflating. This information is then put together with other important health details doctors usually watch. The main idea is to see if this combined approach gives a more complete and accurate picture of how stable the baby is.

Ultimately, researchers hope this new way of monitoring will help doctors make more informed decisions about when a baby needs further breathing support. By having a clearer understanding of a baby's stability, they aim to provide more tailored care, which could lead to better short-term and long-term outcomes for these very delicate infants during a crucial time in their early lives.

Key takeaways

The study looks at new ways to monitor very premature babies after they have breathing tubes removed.
It uses special sensors to check oxygen levels and breathing patterns.
The goal is to help doctors make better decisions about breathing support.
No new medicines or invasive procedures are involved.
Information from the study could lead to improved care for future babies.
Participation is for up to 7 days after breathing tube removal.

Who may be eligible?

This study is looking for tiny babies who meet specific criteria. They must have been born very small, weighing less than 1 kilogram (about 2 pounds, 3 ounces), and also very early, before 28 weeks of pregnancy.

Babies included in the study must have needed a breathing machine within their first three days of life and will be having their first planned removal of the breathing tube within their first six weeks.

Babies cannot take part if they were born with certain health problems, such as major birth defects or heart conditions that were present at birth. The study focuses on babies aged from birth up to 28 weeks of age, and both boys and girls can take part.

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 my baby's birth weight less than 1 kilogram (2 pounds, 3 ounces)?
Was my baby born before 28 weeks of pregnancy?
Did my baby need help from a breathing machine within their first 3 days of life?
Is this the first time my baby is having their breathing tube planned to be removed?
Does my baby have any major birth defects or heart conditions (from birth)? (If yes, they cannot join)
Is my baby currently between birth and 28 weeks of age?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will have special sensors placed on their skin. These include a standard oxygen level probe, which is commonly used, and two additional sensors for the brain and tummy that measure oxygen levels using harmless light (NIR sensors). Another sensor measures breathing patterns from the chest. These sensors simply sit on the skin and gather information; they do not involve needles or medication. The study will monitor these readings, alongside your baby's usual clinical information, for up to 7 days after their breathing tube is removed. There are no additional hospital visits required beyond your baby's routine care.

Potential risks and benefits

Taking part in this study primarily involves using non-invasive sensors, similar to those already used in hospitals, so there are very few expected risks. The main benefit is that the study aims to improve how doctors monitor and care for very premature babies, which could eventually lead to better health outcomes for future babies. You can choose to withdraw your baby from the study at any time without affecting their medical care.

Locations (2)

Centre Hospitalier Universitaire Sainte-Justine
Verified postcode
Montreal, Canada· Recruiting
McGill University Health Center
Verified postcode
Montreal, Canada· Recruiting

Common questions

What kind of babies are included in this study?

This study is for very tiny babies born weighing less than 1 kilogram who needed help with their breathing early on and are having their breathing tube removed for the first time.

Will my baby receive new medicines in this study?

No, this study does not involve any new medicines. It focuses on using different types of monitoring sensors.

Are the sensors safe for my baby?

Yes, the sensors used in this study are placed gently on the skin and are considered safe. They do not involve any pain or invasive procedures.

How long will my baby be monitored for the study?

If your baby takes part, they will be monitored with these special sensors for up to 7 days after their breathing tube is removed.

Will this study change my baby's usual care?

No, your baby will still receive all their standard hospital care. The study aims to gather extra information to help improve monitoring for future babies.

How to find out more

Wissam Shalish, MD, PhD

wissam.shalish@mcgill.ca +1(514) 4124452 Official trial record

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