Active not recruitingNAINTERVENTIONAL

Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation

This research study is about premature babies born between 28 and 32 weeks of pregnancy. The main goal is to understand how these tiny babies react when they have immediate skin-to-skin contact with their mothers after birth, compared to those who receive standard care in an incubator. Researchers will carefully check important body signs like temperature, blood sugar, heart rate, breathing, and oxygen levels. They will also video-record the babies in their first 24 hours and again at three months old to observe their general movements. By comparing these two groups, the study hopes to learn if skin-to-skin contact right after birth has any special benefits for premature babies. About 68 babies will be in each group.

At a glance

Status

Active not recruiting

Phase

Sponsor

Norwegian University of Science and Technology

Enrolment target

108

Start

01 Feb 2014

Estimated completion

01 Dec 2025

Premature Birth

What is this study about?

This study is particularly interested in babies who are born early, specifically between 28 and 32 weeks of pregnancy. This is often called being 'premature.' When a baby is born this early, they are very delicate and need extra care. This study wants to find out if giving these babies immediate skin-to-skin contact with their mothers, also known as 'kangaroo care,' right after birth makes a difference to their early development and well-being.

The researchers will compare two groups of premature babies. One group will gently be placed on their mother's chest for skin-to-skin contact soon after delivery. The other group will receive the usual care, which often means going straight into an incubator. The scientists will be looking closely at several important things like the baby's body temperature, blood sugar levels, heart rate, how they are breathing, and how much oxygen is in their blood. These measurements help them understand how well the baby is coping.

Beyond these physical signs, the study will also use video recordings. They will record the babies in their first day of life and again when they are three months old. This helps them observe how the babies move and develop their general movements. The aim is to see if skin-to-skin contact shortly after birth might have positive effects on these early signs of development for premature babies.

Key takeaways

This study explores the effects of early skin-to-skin contact for premature babies.
It focuses on babies born between 28 and 32 weeks of pregnancy.
Babies will either have early skin-to-skin or go into an incubator right after birth.
Researchers will monitor vital signs and observe development via video recordings.
The study aims to improve care for very premature infants.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for very early babies to take part. To be considered, your baby must be born prematurely, specifically between 28 and 32 weeks of pregnancy.

However, it's very important that your baby is well enough to try either type of care right after birth. If your baby needs urgent medical help immediately after being born, then unfortunately they wouldn't be able to join this study.

If you have a premature baby who fits the age range and doesn't need immediate critical care, then they might be eligible to participate.

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 prematurely?
Was your baby born between 28 and 32 weeks of pregnancy?
Did your baby NOT need urgent medical treatment right after birth?
Is your baby otherwise considered stable enough for either type of care?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will be randomly assigned to one of two groups. This means it's decided by chance, like flipping a coin, whether they receive early skin-to-skin contact or go into an incubator (standard care) right after birth. There will be careful monitoring of your baby's physical signs, such as their body temperature, heart rate, breathing, and oxygen levels. These measurements are routine for premature babies and will be collected as part of the study.

Additionally, your baby will be video-recorded during their first 24 hours of life. Another video recording will take place when your baby is around three months old. These recordings help the researchers observe your baby's movements and development. The study will not involve any medications or treatments other than monitoring and the method of early care (skin-to-skin or incubator). The total duration of active participation for observation and recording would span from birth up to the three-month follow-up.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For your baby, the potential benefits might include providing valuable information that could improve care for premature babies in the future, particularly regarding the role of early skin-to-skin contact. While both skin-to-skin contact and incubator care are common practices, there may be different risks associated with each method, which the study aims to understand; these will be carefully explained by the medical team. You also have the right to withdraw your baby from the study at any time, for any reason, without it affecting your baby's medical care.

Locations (4)

IWK Health Centre
Verified postcode
Halifax, Canada
Nyfødt intensiv, Drammen sykehus
Verified postcode
Drammen, Norway
Nyfødt intensiv, Sørlandet Sykehus
Verified postcode
Kristiansand, Norway
NICU St Olavs Hospital
Verified postcode
Trondheim, Norway

Common questions

What is 'skin-to-skin' contact?

It's when your baby is placed directly on your bare chest, usually with a blanket over them, allowing direct skin contact with you.

Why are babies assigned "randomly"?

Random assignment helps make sure the two groups of babies are as similar as possible, so that any differences found are likely due to the type of care they received.

Will my baby get special care if they are in the study?

All babies receive excellent medical care. This study simply compares two types of immediate care for premature babies: skin-to-skin versus standard incubator care.

What happens if my baby gets sick during the study?

Your baby's health and safety are the top priority. If your baby needs any immediate medical care, they will receive it, and they may need to leave the study.

Will the video recordings be private?

Yes, all data, including video recordings, will be kept confidential and used only for research purposes, with your privacy protected.