RecruitingNAINTERVENTIONAL

E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families

This study is for families with babies born a little early, specifically between 28 and 34 weeks of pregnancy, who were cared for at the UKT hospital. It explores whether a special app can help families and their premature babies in the long run. The app is designed to offer support for both mental and physical health, helping to identify what helps families cope well and what might be challenging. It allows families to record symptoms and needs and connect with the study team. The main goal is to improve the care families receive after leaving the hospital, helping them to feel stronger and better supported. Some families will use the app, while others will receive their usual care, and the study will compare these two groups.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

120

Start

31 Jan 2024

Estimated completion

31 Dec 2027

Preterm Birth

What is this study about?

Imagine you've just had a baby, but they arrived a bit sooner than expected – we call this a premature birth. This can be a challenging time for both the baby and the family. This study is all about finding better ways to support these families after they leave the hospital.

The research aims to understand how an early birth might affect a child's development and their family's well-being over time. We know that the first few months and even years can be crucial for babies born prematurely. This study wants to identify what factors help these children and their families do well, and what might make things more difficult. It's especially interested in how a special app could make a difference.

The app is designed to provide care and support. It allows families to easily record any symptoms or needs their baby might have, and it also offers a way to get in touch with the study team. On top of that, the app provides helpful information and advice to better understand prematurity and its effects. This study developed the app with input from families who have experienced premature birth themselves, as well as experts in caring for premature babies. By comparing families who use the app with those who receive standard care, the study hopes to discover if this app-based approach can improve the well-being of premature babies and their families.

Key takeaways

The study helps families with babies born a bit early.
It uses a special app to offer support and gather information.
The goal is to improve care after leaving the hospital.
Families either use the app or receive standard care for comparison.
Your insights could help other families in the future.
You can stop taking part at any time.

Who may be eligible?

To be part of this study, your baby must have been born prematurely at the UKT hospital, specifically between 28 and 34 weeks of pregnancy. You, as the mother, need to be at least 18 years old.

It's important that you're comfortable speaking German and have a reliable way to access the internet, either on a smartphone or tablet, as the study involves using a special app. You'll also need to agree to take part and sign a consent form.

However, this study might not be right for families whose baby was born much earlier (before 28 weeks) or later (after 34 weeks). Also, if your baby has serious brain or nerve problems, or significant birth defects, they wouldn't be able to join. If you don't have internet access or a suitable device, or if German isn't your main language, you wouldn't be able to take part either.

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 between 28 and 34 weeks of pregnancy?
Was your baby born at the UKT hospital?
Are you, the mother, 18 years old or older?
Do you have a smartphone or tablet with internet access?
Are you comfortable understanding and speaking German?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your family will be either given access to a special app (the 'intervention group') or you will receive the usual care that premature babies and their families get after leaving the hospital (the 'treatment as usual group'). The study will involve checking in with you and your baby several times after hospital discharge: once shortly after you go home, then again about four months after your baby's original due date, and finally another two months after that. Some families might also be invited to join a small group discussion to share their experiences. The total duration of your family's participation in the study will be for several months.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving extra support and information through the app, which could help you feel more confident and connected. It also contributes to research that may improve care for other families in the future. As with any study, there's always a small chance of minor inconvenience, such as the time it takes to use the app or participate in assessments. All personal information will be kept confidential. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect the care you or your baby receive.

Locations (1)

University Hospital Tuebingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is a 'premature baby' in this study?

In this study, a premature baby is one born between 28 and 34 weeks of pregnancy.

What does the app do?

The app helps you record your baby's symptoms and your needs, connects you with the study team, and provides helpful information.

Will my baby get extra medical treatment?

No, the study isn't about new medical treatments, but about supporting families and understanding their needs after leaving the hospital.

Do I need to speak German?

Yes, for this specific study, sufficient knowledge of German is required.

What if I don't have internet access?

Internet access is a requirement for mothers to participate in this study, as the app is central to it.

How to find out more

Annette Conzelmann, Prof.Dr.

annette.conzelmann@med.uni-tuebingen.de 00497071/29-87513 Official trial record

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