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RecruitingNAINTERVENTIONAL

Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants

This study is investigating if having immediate skin-to-skin contact between mothers and their babies right after a vaginal birth can help babies born a little early. These are babies born between 32 and 37 weeks of pregnancy. The researchers want to see if this early contact changes how the baby's body reacts to stress at a very basic level and if it leads to better health and development as they grow up. Some babies will have skin-to-skin contact straight away, while others will be cared for separately at first. By comparing these two groups, the study hopes to understand the benefits of immediate skin-to-skin contact for these preterm babies.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Cologne
Enrolment target
60
Start
04 Aug 2023
Estimated completion
31 Dec 2028

What is this study about?

This study is looking into the benefits of immediate skin-to-skin contact for babies who are born a little early, specifically between 32 and 37 weeks of pregnancy. You might have heard of this type of contact as 'kangaroo care'. Usually, after birth, some babies are immediately separated from their mothers for various reasons, but this study suggests there might be important advantages to keeping them together right away.

The main idea behind this research is to see if immediate skin-to-skin contact changes how a baby's body develops its ability to handle stress. They are looking at this at a very tiny, biological level (called 'gene expression'). The researchers believe that this early contact could set up the baby for better overall health, social skills, and brain development in the long run.

By comparing babies who have immediate skin-to-skin contact with those who don't, the study hopes to show a clear link between this simple act and a baby's ability to cope with stress throughout their life. This could help us understand more about how early experiences shape a baby's future wellbeing.

Key takeaways

  • The study explores the benefits of immediate skin-to-skin contact for babies born a bit early.
  • It aims to understand how this contact affects babies' ability to cope with stress.
  • Researchers hope it leads to better long-term development for these babies.
  • Participation involves being randomly assigned to immediate skin-to-skin or initial separation.
  • The study focuses on babies born vaginally between 32 and 37 weeks.
  • Your involvement could help improve future care for preterm infants.

Who may be eligible?

To take part in this study, you would need to be expecting a baby that is likely to be born a little early, specifically between 32 and 37 weeks of pregnancy. Your baby must be born vaginally, not by C-section, and it should be a single birth, meaning you're not having twins or more. We would also need to get your permission to take part in the study before your baby is born.

There are some reasons why you wouldn't be able to join the study. For example, if your baby has any birth defects or needs medical help right after being born (like resuscitation). You also wouldn't be able to participate if you have a serious medical or mental health condition. Finally, if you don't speak German, you wouldn't be able to join this particular 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.

  1. Is my baby expected to be born between 32 and 37 weeks of pregnancy?
  2. Am I planning to have a vaginal birth?
  3. Am I expecting just one baby (not twins or more)?
  4. Do I speak German?
  5. Does my baby have any known birth defects or serious health issues?
  6. Do I have any serious ongoing medical or mental health conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be placed into one of two groups by chance, like flipping a coin. One group will have immediate skin-to-skin contact with their baby right after a vaginal birth. The other group will have their baby cared for separately at first. The study will involve carefully observing your baby and collecting information from them. This will include looking at very tiny markers in their body to understand how stress is handled. The researchers will then follow up to see how your baby develops over time. The exact number of visits or the total length of the follow-up isn't detailed, but it aims to look at both short-term and long-term outcomes for your baby.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While there are no direct benefits guaranteed, your participation could help us learn more about the best ways to care for babies born a little early, potentially helping many families in the future. The risks of this study are generally low, as it involves common care practices. If you are allocated to the immediate skin-to-skin group, it is a practice known to have many potential benefits. If you are in the other group, your baby will still receive standard medical care. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your or your baby's treatment.

Locations (1)

  • University hospital of Cologne, Department of Neonatology
    Verified postcode
    Cologne, Germany· Recruiting

Common questions

What is 'skin-to-skin contact'?

It's when your baby is placed directly onto your bare chest, usually with a blanket over them for warmth. It's also called 'kangaroo care'.

What does 'preterm birth' mean in this study?

It means your baby is born a little early, specifically between the 32nd and 37th week of pregnancy.

Will I get to choose if I have skin-to-skin contact?

No, your group will be decided by chance, like drawing lots. This helps make the study fair.

What if my baby needs medical attention after birth?

If your baby needs serious medical help, they wouldn't be able to join the study, and they would receive the critical care they need first.

What does 'stress signalling pathway' mean for my baby?

It's a scientific way of saying they're looking at how your baby's body naturally reacts to and handles stress, at a very basic level.

How to find out more

Katrin Mehler, PD Dr.

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

Interested in taking part?

Register your interest

Share your details and the research team for "Continuous Delivery Room Skin-to-skin-study for Moderate and…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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