RecruitingNAINTERVENTIONAL

Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.

This research, called NeoDeco, is looking into how a special way of caring for very premature babies can help prevent serious infections. We call this 'optimised kangaroo care,' where babies have lots of skin-to-skin contact with a parent. This study aims to see if making sure this type of care is done in a very specific, best-practice way in neonatal units can reduce infections caused by bacteria, especially those that are hard to treat. We're focusing on babies born before 32 weeks, who are particularly vulnerable. The study is running in several European countries, including the UK, to find out if this improved care makes a real difference in keeping these tiny babies healthier.

At a glance

Status

Recruiting

Phase

Sponsor

PENTA Foundation

Enrolment target

3,080

Start

28 May 2024

Estimated completion

01 May 2026

Infection, Bacterial Infection Prevention

What is this study about?

This study is called NeoDeco and it's all about making sure very premature babies stay healthy and don't get serious infections while they're in the hospital. Premature babies, especially those born before 32 weeks, are very delicate and can easily pick up infections. These infections can be quite serious and sometimes difficult to treat.

The research is looking at something called 'kangaroo care,' which you might know as skin-to-skin contact. This is when a parent holds their baby directly on their chest, skin-to-skin. We know kangaroo care is good for babies, but this study specifically looks at what we call 'optimised kangaroo care.' This means doing kangaroo care in a very particular, consistent way, following the best advice from experts worldwide. The goal is to see if by improving how and how often kangaroo care is given, we can significantly reduce the number of serious infections in these vulnerable babies.

The study involves several neonatal units (special baby units) across different European countries, including some in the UK. Some units will continue with their usual care, and others will introduce this 'optimised kangaroo care' with extra training and support for the staff. By comparing these groups, the researchers hope to understand if putting more efforts into this special type of care can really make a difference in preventing infections and helping these tiny babies thrive.

Key takeaways

The study aims to reduce serious infections in very premature babies.
It focuses on 'optimised kangaroo care' (skin-to-skin contact) in neonatal units.
No new medicines or treatments are involved.
Information will be collected from medical records and samples.
Your decision to participate is voluntary and won't affect your baby's care.
The study is happening in several European countries, including the UK.

Who may be eligible?

This study is looking for neonatal units in hospitals that care for very premature babies (those born before 28 weeks) and have at least 12 beds. They also need to be able to store samples in a very cold freezer and be willing to adopt the special 'optimised kangaroo care' if they are chosen for that part of the study.

For babies, the study will include all babies born before 32 weeks who are admitted to the participating neonatal units. There are no specific reasons a baby would be excluded from the data collection, as long as their parents agree for them to take part. The only reason a baby's information wouldn't be collected individually is if their parents decide not to give their permission.

Hospitals can't take part if they're already involved in other research that might interfere with this study, or if they're already providing a very high amount of skin-to-skin contact (more than 18 hours a day on average). Also, if there are expected to be big changes in how they deal with resistant bacteria during the study, they might not be able to participate.

Quick self-check

Is my baby born before 32 weeks' gestation?
Is my baby being cared for in a participating NHS neonatal unit?
Am I willing for my baby's health information and samples to be used for research?
Do I agree for my baby to be part of a unit that might offer 'optimised kangaroo care' if chosen for that group?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you and your baby are part of this study, your baby will receive care in a neonatal unit that is either continuing with its usual practices or has introduced 'optimised kangaroo care.' This means staff will receive extra training and support to ensure skin-to-skin contact is offered frequently, for longer periods, and started as early as possible. Exactly what's involved for your baby will depend on which group your unit is in. If your unit is in the 'optimised kangaroo care' group, your baby will have more opportunities for skin-to-skin contact with you or another parent, guided by the healthcare team.

The study will involve collecting clinical information about your baby's health from their medical records, such as details about any infections they might get. We will also collect small biological samples, like swabs, from consented babies. There are no extra visits or special medications involved just for the study. The total duration of data collection for your baby will be during their time in the neonatal unit. You have the right to withdraw your consent for your baby's individual data and samples to be collected at any time, without affecting their care.

Potential risks and benefits

The main benefit of this study could be that if 'optimised kangaroo care' proves effective, it could lead to fewer serious infections for premature babies, helping them to be healthier and potentially go home sooner. This improved care might also strengthen the bond between parents and their babies. For babies taking part, the risks are minimal as it focuses on an established care practice (kangaroo care) in an organised way; there are no new medications or invasive procedures. The primary involvement is the collection of medical data and samples. You have the right to withdraw your child's data and samples from the study at any time, and this will not affect the standard of care your baby receives in any way.

Locations (24)

Aglaia Kyriakou Children's Hospital
Athens, Greece· Recruiting
University General Hospital Attikon
Attiki, Greece· Completed
University Hospital of Heraklion
Heraklion, Greece· Completed
Ioannina University Hospital
Ioannina, Greece· Completed
University General Hospital of Patras
Pátrai, Greece· Recruiting
Hippokration Hospital - Thessaloniki
Thessaloniki, Greece· Completed
Papageorgiou Hospital
Thessaloniki, Greece· Completed
Azienda Ospedaliera Universitaria S.Anna di Ferrara
Ferrara, Italy· Recruiting
Azienda Ospedaliera Universitaria di Modena
Modena, Italy· Recruiting
Ospedale Universitario Policlinico Paolo Giaccone
Palermo, Italy· Recruiting
Ospedale San Bortolo di Vicenza
Vicenza, Italy· Recruiting
Hospital General Universitario Alicante
Alicante, Spain· Recruiting

+12 more sites — see the official record for the full list.

Common questions

What is 'kangaroo care'?

Kangaroo care is a way of holding your baby skin-to-skin on your chest. It's known to have many benefits for premature babies.

What does 'optimised' kangaroo care mean?

It means doing kangaroo care in a very specific, consistent way, following the best guidelines for how often, how long, and when it should start, to get the most benefits.

Will my baby get any extra medicines?

No, your baby will not receive any extra medicines as part of this study. It's about how care is provided, not about new treatments.

What kind of information will be collected about my baby?

Researchers will collect information from your baby's medical records about their health and any infections they might get. Small samples may also be collected with your permission.

Can I decide not to let my baby take part?

Yes, taking part is completely voluntary. You can choose not to allow your baby's individual data and samples to be collected, and this will not affect their medical care.

How to find out more

Selene Parenti

selene.parenti@pentafoundation.org +39 378 309 4518 Official trial record

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