Not yet recruitingNAINTERVENTIONAL

Interest of Nurse Participation During Epicutaneous-cavity Catheter Placement in Neonatal Intensive Care

This study is exploring a way to make a necessary procedure for premature babies less stressful. Babies in intensive care sometimes need a special long-term drip called a KTEC inserted into a vein. Currently, doctors often do this on their own. This can sometimes take a few tries, which can be upsetting and painful for the baby. Doctors at a hospital in France are trying to see if having a specially trained nurse help during the procedure, working alongside the doctor, could make a difference. They believe that this "four-hands" approach might reduce the number of attempts needed to insert the drip and lessen the baby's pain. This initial study will randomly assign babies to either the current method or the new team approach to compare the results safely.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

Start

01 Jul 2025

Estimated completion

04 Feb 2027

Premature Birth

What is this study about?

When premature babies are in intensive care, they often need special medical care that involves giving them medicines or nutrients directly into their bloodstream. For this, doctors use a thin, flexible tube called a percutaneous central venous catheter, also known as a KTEC. This tube is carefully placed into a vein and can stay there for a longer time, which means fewer needle pokes for the baby.

Currently, in some hospitals, a doctor usually performs this procedure alone. However, inserting this tube can sometimes be tricky and might require several attempts. Each attempt can be painful and upsetting for the baby, and repeated pain can potentially affect their development. This study wants to find out if having a trained nurse work together with the doctor to insert the KTEC could make the process smoother.

Researchers think that with a nurse's help, the procedure might be successful with fewer attempts, leading to less pain and distress for the baby. This study will compare the usual method with this new teamwork approach to see if it makes a positive difference for these very sensitive patients.

Key takeaways

The study aims to reduce discomfort for premature babies during a common procedure.
It compares a doctor working alone vs. a doctor and a trained nurse for KTEC insertion.
The goal is fewer needle attempts and less pain for the baby.
Participation involves observation during a single, necessary medical procedure.
Your decision to participate or withdraw will not affect your baby's treatment.

Who may be eligible?

This study is looking for premature babies who need a KTEC inserted. To be considered, your baby must have been born between 25 and 42 weeks of pregnancy. Their parents or legal guardians must be over 18 years old and able to understand and agree to the study in French.

There are also some reasons why a baby might not be able to join the study. For example, if a parent is under legal guardianship, deprived of their freedom, or doesn't speak or understand French, their baby cannot take part. Babies who were placed for adoption at birth (meaning their birth parents are unknown) also cannot be included.

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 your baby a premature newborn who needs a KTEC (long-term drip)?
Were they born between 25 and 42 weeks of pregnancy?
Are you, as a parent or guardian, over 18 years old?
Do you speak and understand French well enough to give informed consent?
Are you able to provide legal consent for your baby?

Answer every question to see your result.

What does participation involve?

If you agree for your baby to join the study, it will involve them having their KTEC insertion procedure observed. Before the study starts, a group of nurses will receive special training on how to assist with KTEC insertions. If your baby needs a KTEC and you agree for them to take part, they will be randomly chosen to either have the procedure done by a doctor alone (the usual way) or by a doctor working with a specially trained nurse.

The study will focus on what happens during this one procedure. Researchers will collect information from the time the first needle attempt is made until the successful KTEC is in place and dressed, or until the procedure has to stop if it’s unsuccessful. A nurse involved in the procedure will fill out a form to record details like the number of attempts and observations about the baby's comfort. The overall inclusion period for the study is 18 months, but your baby's direct participation will only cover the duration of the KTEC insertion procedure.

Potential risks and benefits

The potential benefit of joining this study is that, if the team approach is proven effective, it could lead to quicker, less painful KTEC insertions for babies in the future. For your baby, they might experience fewer attempts during the procedure. The risks are minimal, as the procedure itself is medically necessary irrespective of the study. There's no change in the type of KTEC or medical care, only in how many people are involved in inserting it. You are completely free to withdraw your consent for your baby to be in the study at any time without it affecting their medical care.

Locations (1)

CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France

Common questions

What is a KTEC?

A KTEC is a special long, thin tube that doctors place into a baby's vein. It's used to give medicines or nutrients for a longer time without needing repeated needle pokes.

Why is this study being done?

The study wants to see if a trained nurse helping the doctor insert this tube can make the process quicker, less stressful, and less painful for premature babies.

Will my baby's care be different if they join?

Your baby will still receive the best possible medical care. The only difference is whether the KTEC is inserted by a doctor alone or by a doctor working with a specially trained nurse, depending on which group your baby is randomly assigned to.

Is this a new procedure?

No, the KTEC insertion itself is a standard procedure. This study is just looking at different ways of performing it to improve the experience for babies.

Can I change my mind about my baby being in the study?

Yes, you can decide to withdraw your baby from the study at any time, even if you've already given consent. Their medical care will not be affected.

How to find out more

Lise Laclautre

promo_interne_drci@chu-clermontferrand.fr 334.73.754.963 Official trial record

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