RecruitingNAINTERVENTIONAL

The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program

This study, called 'The Alberta Neonatal Abstinence Syndrome Mother-Baby Care ImprovEmeNT Program', is looking into a better way to care for babies born after being exposed to drugs during pregnancy. These babies can have some difficult symptoms, but research suggests that keeping them with their mothers in a calm, supportive hospital environment, known as 'rooming-in', can be very beneficial. This approach has been found to reduce the need for babies to go into special baby units (NICU) and shorten their stays if they do. It also encourages breastfeeding and helps more babies go home with their mothers. This study aims to bring this 'rooming-in' care to hospitals in Alberta to see if it can improve care for both mothers and babies and potentially save costs.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

240

Start

01 Oct 2023

Estimated completion

30 Nov 2026

Neonatal Abstinence Syndrome

What is this study about?

This study is about helping babies born after being exposed to certain drugs during pregnancy, a condition sometimes called Neonatal Abstinence Syndrome (NAS). Caring for these babies can be tricky, as they might have problems like poor feeding, tummy upsets, or be very irritable. Often, they end up needing special care in a unit called the Neonatal Intensive Care Unit (NICU). This can mean mothers and babies are separated at a really important time for bonding.

However, new research shows that keeping mothers and babies together in the hospital, in what's called 'rooming-in' care, can make a big difference. This means staying in a quiet, supportive space where they can be close. Studies have found that this approach can reduce how often babies need to go to the NICU, and if they do go, they spend less time there. It also helps mothers to breastfeed more and means more babies can go home with their mums, which is better for everyone.

This project will introduce this 'rooming-in' care into hospitals across Alberta in a careful and organised way. The main goal is to see if this new approach can lower the number of babies needing NICU care and how long they stay there. The researchers also want to see if it helps more babies go home with their mothers, increases breastfeeding, and encourages mothers to join support programmes for drug use. They'll also check if this type of care saves money for the healthcare system and society overall.

Key takeaways

This study explores a 'rooming-in' approach for mothers and babies affected by drug exposure during pregnancy.
The main goal is to help babies stay out of intensive care and allow mothers and babies to bond.
It aims to increase breastfeeding rates and help mothers connect with support programmes.
The care combines mother-baby closeness with medical support to improve outcomes.
The study hopes to show this approach is better for families and possibly more cost-effective.
You can choose to join or leave the study at any time without affecting your care.

Who may be eligible?

This study is for babies born at 36 weeks or later (near full term) whose mothers reported using opiate drugs during pregnancy or who are part of a special support programme for opiate use. The mother and baby must also be receiving care at one of the hospitals taking part in this study.

Babies will not be able to join the study if they are born earlier than 36 weeks, weigh less than 2 kilograms (about 4 pounds, 6 ounces) at birth, or have certain birth defects. These babies typically need intensive care anyway, which is why they wouldn't be suitable for this type of ‘rooming-in’ study.

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 expected to be born at 36 weeks or later?
Have I reported using opiate drugs during my pregnancy or am I in an opiate support programme?
Will I be giving birth at one of the hospitals taking part in this study?
Is my baby expected to weigh at least 2 kg (about 4 lbs 6 oz) at birth and not have any serious birth defects?

Answer every question to see your result.

What does participation involve?

If you and your baby join the study, you'll be part of a hospital programme that focuses on keeping mothers and babies together after birth. This means you and your baby would stay in the same room, with support from staff. Doctors and nurses will check how your baby is doing and how well you are coping. They will also look at things like whether your baby needs medication, how well they are feeding (including breastfeeding), and if you get involved in support groups for drug use.

Some information will also be collected about your well-being, how confident you feel as a parent, and your quality of life both when you leave the hospital and again six months later. For your baby, their development will be checked at six months using a special questionnaire. This study will happen as part of your care in the hospital and there will be follow-up checks at 6 months.

Potential risks and benefits

The potential benefits of taking part include your baby potentially spending less time in special care and a greater chance for you and your baby to stay together and bond. This approach is also linked to higher rates of breastfeeding. There aren't many known risks, as 'rooming-in' is a supportive care approach designed to help. However, as with any study, there's always a chance that the care might not work as well for everyone, or that some aspects might not be what you expect. You are free to withdraw from the study at any time without it affecting your or your baby's standard medical care.

Locations (1)

University of Alberta
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is 'rooming-in' care?

'Rooming-in' care means that you and your baby stay together in the same hospital room, with support from nurses and doctors, after your baby is born.

What is Neonatal Abstinence Syndrome (NAS)?

NAS can affect babies who were exposed to certain drugs during pregnancy. They might show symptoms like being irritable, having feeding problems, or tummy upsets.

Will my baby still get medication if needed?

Yes, if your baby needs medication for their symptoms, they will still receive it as part of their care.

What happens if I don't want to join the study?

If you choose not to join the study, or if you decide to leave it later, your medical care and your baby's care will not change.

How long will the study follow me and my baby?

The study will collect information during your hospital stay and then have a follow-up check at six months after your baby is born.

How to find out more

Matt Hicks, MD, PhD

mhicks1@ualberta.ca 780-492-1772 Official trial record

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