Clinical trial NCT06813326: Interest of Nurse Participation During Epicutaneous-cavity Catheter Placement in Neonatal Intensive Care
Official title: Interest of Nurse Participation During Epicutaneous-cavity Catheter Placement in Neonatal Intensive Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: newborn
neonatal intensive care
percutaneous central venous catheter
nurse
pain
shots
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 96
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: In the neonatal intensive care unit (NICU) of the University Hospital of Clermont-Ferrand (63), the study will begin with the training of a group of nurse practitioners (I(P)DE) to perform KTEC insertions in pairs over a six-month period. After this training, if a KTEC insertion is required, the investigator will ask the parents or guardians of eligible newborns for their consent to participate in the IPICAVE study (pre-inclusion visit).

If they agree, inclusion/randomization will take place after the parents or legal guardians sign the informed consent form for study participation.

The inclusion period will last for 18 months, and the study participation for each newborn will begin with the first needle insertion during the procedure and end at the conclusion of the dressing change after successful KTEC insertion or upon the last needle insertion if the attempt fails. During the KTEC insertion, the responsible I(P)DE will complete a data collection form to assess the various study criteria.

Eligibility criteria: 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 outcomes:
measure: Successfull of KTEC insertion
timeFrame: within day 3
Secondary outcomes:
measure: success rate of the procedure.
timeFrame: within day 3
Other outcomes:
measure: pain evaluation
timeFrame: within day 3
measure: number of insertion attempts in cases of previous failure
timeFrame: within day 3
measure: procedure time
timeFrame: within day 3
measure: Study the factors associated with the total number of bites
timeFrame: within day 3
measure: Study factors associated with average and maximum pain in newborns
timeFrame: within day 3
measure: hemoglobin levels
timeFrame: within day 3
measure: Study the factors associated with the total number of bites
timeFrame: within day 3
measure: Study factors associated with average and maximum pain in newborns
timeFrame: within day 3
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Nathalie SATURNIN LENOBLE
role: PRINCIPAL_INVESTIGATOR
References: