RecruitingNAINTERVENTIONAL

NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment

This study, called NeuroN-QI, is looking at ways to help premature babies develop better. It involves special care that includes parents holding their baby skin-to-skin while speaking gently, and also quiet times in the incubator with soothing smells like breast milk. These calming experiences, combined with careful light and noise levels, are thought to help a baby's brain grow and develop well. Researchers want to compare babies who receive this special care with those who receive standard skin-to-skin contact. The aim is to see if this extra support makes a positive difference for babies born early.

At a glance

Status

Recruiting

Phase

Sponsor

St. Justine's Hospital

Enrolment target

124

Start

23 Nov 2023

Estimated completion

01 Oct 2027

Neurodevelopmental Disorders

What is this study about?

This study is called NeuroN-QI, and it focuses on helping premature babies – babies born early – develop as well as possible. We know that the first few weeks and months are really important for a baby's brain growth. This study is testing a special approach that combines several gentle ways to support this development.

First, it involves parents having skin-to-skin contact with their baby, often called 'kangaroo care'. During this time, parents will also speak gently to their baby. Second, it includes calm periods for the baby in their incubator or cot, where they are not disturbed. During these calm times, the baby might smell breast milk, which can be very comforting. All of these steps are done while carefully controlling the light and noise around the baby. The idea is that these gentle experiences help create a good environment for the baby's brain to develop.

By comparing babies who receive this special care with those who receive standard skin-to-skin care, researchers hope to learn if these combined approaches can make a real difference in how premature babies grow and develop, especially their brain functions.

Key takeaways

Focuses on improving premature baby development through gentle care.
Involves skin-to-skin contact, gentle speaking, and calming periods.
Uses breast milk smell and controlled light/noise levels.
Aims to encourage good brain growth in early-born babies.
Parents play an active role in providing care.
No new medications are given as part of the study.

Who may be eligible?

Premature babies between 24 and nearly 34 weeks of pregnancy (gestational age) who are well enough for skin-to-skin contact may be able to join. Both mothers and fathers are invited to take part if they can commit to at least one skin-to-skin session per week with gentle talking until their baby reaches 36 weeks gestational age. Mothers must be able to provide breast milk for their baby. If a baby is a twin, both twins can participate if their father also takes part.

Babies would not be able to join if they have certain health conditions like genetic problems, significant bleeding in the brain, or are very small for their gestational age. Babies who are still on strong pain relief, calming medicines, paralysing medicines, or breathing machines would also not be eligible.

Parents would not be eligible if they are under 18, have a physical condition making skin-to-skin contact difficult, or use alcohol or drugs in a way that might affect their interactions with their baby. Mothers who have had breast surgery that could stop them producing milk, or parents who only feed their baby commercial formula would also not be able to join. Parents must be able to speak, read, or write in French or English.

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 born between 24 and nearly 34 weeks of pregnancy?
Is my baby well enough for skin-to-skin contact?
Am I able to do skin-to-skin contact with gentle talking at least once a week?
Am I able to provide breast milk for my baby?
Do I speak, read, or write in French or English?
Does my baby have any major health conditions like significant brain bleeding or genetic problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your baby will receive either the special combination of care (skin-to-skin, gentle sounds, calming periods with breast milk smell) or standard skin-to-skin care. The key part for parents is to have at least one skin-to-skin session each week with their baby, including 10 minutes of gentle talking, until your baby reaches what would have been 36 weeks of pregnancy. Mothers will also need to provide breast milk for their baby. There are no specific additional visits or assessments mentioned beyond these care practices. The study aims to start around 19 days after your baby's birth and continues until your baby reaches 36 weeks gestational age. There are no medications involved in this study.

Potential risks and benefits

The potential benefits of joining this study include receiving focused, gentle care that might improve your premature baby's brain development and overall well-being through increased parent-baby bonding and a calming environment. There are no known direct risks to your baby or you from the interventions themselves, as they involve supportive, gentle care methods. As with any study, there's always a small chance that the new intervention might not work as expected or that unknown effects could occur, but the care provided is based on supportive approaches. You are always free to withdraw from the study at any time without affecting your baby's medical care.

Locations (2)

CHU Sainte-Justine
Verified postcode
Montreal, Canada· Recruiting
CUSM
Verified postcode
Montreal, Canada· Not yet recruiting

Common questions

What is 'skin-to-skin contact'?

Skin-to-skin contact means holding your baby directly against your bare chest, often with a blanket over both of you for warmth. It's also known as 'kangaroo care'.

Will my baby get extra checks or tests if we join?

The information provided does not mention additional checks or tests for your baby beyond their usual hospital care. The study focuses on how care is delivered.

Do I have to speak to my baby during skin-to-skin contact?

Yes, part of this study involves speaking gently to your baby for 10 minutes during each skin-to-skin session. Your voice is a comforting sound for your baby.

What if I can't express breast milk?

Providing breast milk is an important part of the study for mothers, as the smell of breast milk is used in the baby's calming periods. If you can't express breast milk, you may not be able to join.

How long does the study last for my baby?

Your baby's participation in the specific care practices will continue until they reach what would have been 36 weeks of pregnancy.

How to find out more

Marilyn Aita, Ph.D.

marilyn.aita@umontreal.ca 514-343-6111 Official trial record

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