Interest of Nurse Participation During Epicutaneous-cavity Catheter Placement in Neonatal Intensive Care
Condition(s) studied
Investigational drug(s) / intervention(s)
catheter insertion: success of catheter insertion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Successfull of KTEC insertion — within day 3
Total number of injections until successful KTEC insertion.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06813326 on ClinicalTrials.gov ↗ ← All trials in France