RecruitingOBSERVATIONAL

Acceptability and Feasibility of Implementing a Coordinated Hospital/Non-hospital Parenting Support and Prevention Program for Families of Infants at High Neurodevelopmental Risk After Neonatal Intensive Care Hospitalization

This project, called PRéPaR, is creating a new support program for families whose babies are at a higher risk of developing difficulties with their brain and movement after spending time in hospital intensive care. Doctors, nurses, and parents are all working together to design this program. The main goals are to help parents feel more confident in looking after their baby, support their baby's development, and make sure there's a smooth link between hospital care and care at home. This includes spotting early signs of movement problems and continuing any support that started in hospital. The study will check if this program is welcomed by families and staff, and if it can be put into practice easily.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

Start

09 Jan 2023

Estimated completion

01 Nov 2025

Neurodevelopmental Motor Disorders

What is this study about?

When a baby is born early or with certain health issues, they sometimes need special care in a hospital's intensive care unit. This can mean they have a higher chance of developing problems later on, especially with how their brain develops and how they move. This study, called PRéPaR, is all about helping these families.

The researchers want to work with parents and healthcare professionals, like physiotherapists and nurses, to create a special support program. This program is designed to do a few important things: help parents learn skills to support their baby's development, make sure there's good communication between the hospital team and the support available outside of hospital, and identify any movement difficulties early so babies can get help as soon as possible.

Ultimately, the study wants to find out if this new support program is helpful for families and easy to put into practice. By improving support for these families, the hope is to give babies the best possible start and help them reach their full potential.

Key takeaways

The study helps design support for families with babies at developmental risk.
It aims to bridge care between hospital and home.
Parents and healthcare professionals are working together.
Focus groups are used to gather ideas and feedback.
The goal is to improve parenting skills and infant development.
It checks if the program is acceptable and practical to use.

Who may be eligible?

This study is looking for parents with babies who have had certain health challenges, putting them at a higher risk of developmental problems. There are two main groups of parents needed for different parts of the study.

One group is parents of children aged between 18 months and 4 years old (after adjusting for prematurity, if applicable). Their child must have had a risk factor at birth, such as being very premature (born before 32 weeks), weighing less than 1.5kg, having experienced a stroke or other specific brain scan findings, and currently showing signs of developmental difficulties with movement, such as cerebral palsy.

The second group of parents has babies aged between 34 weeks (corrected age) and 12 months (corrected age) when the study starts. These babies also need to have had specific risk factors at birth, like being very premature, weighing less than 1.5kg, or having had a stroke or certain brain scan findings. Additionally, healthcare professionals who work with these children and their families, like physiotherapists and nurses, are also invited to 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 child aged between 18 months and 4 years (corrected age) AND has known movement difficulties?
OR is my child aged between 34 weeks and 12 months (corrected age)?
Did my child have a risk factor at birth (e.g., very premature, low birth weight, certain brain conditions)?
Can I attend up to three discussion meetings?
Am I a healthcare professional involved in supporting these families?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will depend on which part of the study you participate in.

For parents, this mainly involves taking part in up to three group discussions, called 'focus groups'. These groups are a chance for you to share your experiences and ideas to help design the support program. The discussions will be spread out over time. You will also be asked to complete some questionnaires about your child's development and how satisfied you are with the care received. For healthcare professionals, participation also involves focus groups and providing feedback on the care provided.

The study aims to understand what kind of support works best for families and how well the new program is received. The total duration of your participation will depend on the discussions and evaluations planned.

Potential risks and benefits

Taking part in this study could offer some benefits, such as having your voice heard in designing a valuable support program for families like yours, which might help others in the future. You'll also be contributing to important research that could improve care for babies at risk. As with any study, there could be some small risks, primarily giving up your time for the discussions. Your personal information will be kept private. You have the right to withdraw from the study at any time, for any reason, without it affecting your or your child's medical care.

Locations (1)

Chu Dijon Bourgogne
Verified postcode
Dijon, France· Recruiting

Common questions

What does 'neurodevelopmental risk' mean?

It means a baby has a higher chance of developing problems with how their brain grows and functions, which can affect things like movement, learning, and communication.

What is a 'focus group'?

A focus group is a discussion with a small group of people who share similar experiences. It's a way for researchers to gather opinions and ideas on a specific topic.

Who is running this study?

This study is called the PRéPaR project, and it involves researchers and healthcare professionals aimed at improving care for babies at risk.

Will my child receive treatment in this study?

This study is focused on developing and evaluating a support program, not on providing new treatments. However, by participating, you'll help shape future support and care.

What does 'corrected age' mean?

Corrected age (or adjusted age) is your baby's age based on their original due date, rather than their birth date. This is used for babies born prematurely.

How to find out more

Sandrine JANDET CARON

sandrine.jandet@gmail.com 0672089035 Official trial record

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