NCT06813326: IPICAVE

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

Not yet recruiting NA Last updated 6 February 2025

What this trial tests

NA trial testing catheter insertion in Premature Birth in 96 participants. Not yet recruiting.

Timeline

1 July 2025

Primary endpoint
4 February 2027

4 February 2027

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	96
Start date	1 July 2025
Primary completion	4 February 2027
Estimated completion	4 February 2027
Sites	1 location across France

Drugs / interventions tested

• catheter insertion

Conditions studied

• Premature Birth — all drugs for Premature Birth →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

Under 3 Months, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To meet the needs of newborns in neonatal intensive care and ensure long-term venous access, a percutaneous central venous catheter (KTEC) is inserted. According to the recommendations of the French Society of Hospital Hygiene, the placement of this device is the responsibility of a medical professional. It may require several attempts to ensure the success of the procedure.

The pain associated with the needle insertion is generally controlled, but with repeated attempts, the newborn may become agitated, cry, and be difficult to calm. The study by Courtois et al. showed that pain in infants under 45 weeks of gestational age increased with the number of attempts. Acute and repeated pain in newborns can lead to trauma and disturbances in psychological, cognitive, and motor development.

In the neonatal intensive care unit (NICU) at the University Hospital of Clermont-Ferrand, the procedure is performed by the physician alone (i.e., "two hands"), whereas in other NICUs in France, the procedure is systematically performed by a nurse/physician team (i.e., "four hands"). However, no comparative study has been conducted to date to assess the impact of this "four hands" approach on the number of needle attempts and the pain experienced by the newborn.

The investogator hypothesize that the training and participation of the nurse (pediatric nurse) during the placement of the KTEC, in collaboration with the physician, could reduce the number of needle attempts and the newborn's pain. Therefore, the investigator aim to conduct a randomized, monocentric pilot study in the neonatal intensive care unit at the University Hospital of Clermont-Ferrand.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.