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Starting soon Not applicable

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

NCT06813326 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-07-01
Last updated
2025-02-06

Condition(s) studied

Premature Birth

Investigational drug(s) / intervention(s)

catheter insertion

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

Sex
ALL
Min age
—
Max age
3 Months
Healthy volunteers
Accepted
Inclusion Criteria: * Newborns born between 25 and 42 weeks of amenorrhea requiring KTEC insertion * Newborn whose parents or guardians have been informed of the study and are capable of providing informed consent to participate in the research. * Informed consent obtained from parents or guardians * Parents of legal age (≥18 years) Exclusion Criteria: * Parents under guardianship or curatorship, deprived of liberty or under court protection * Parents who do not speak or understand French * Newborn born under X

Primary outcome measure(s)

  • Successfull of KTEC insertion — within day 3
    Total number of injections until successful KTEC insertion.

Trial sites (1)

FacilityCityRegionStatus
CHU Clermont-Ferrand Clermont-Ferrand France
Official registry record

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