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

NCT06813326 | Not Yet Recruiting

• 1 other identifier: AOI 2023 SATURNIN
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

newborn; neonatal intensive care; percutaneous central venous catheter; nurse; pain; shots

Outcome Measures

Primary Outcomes (1)

• Successfull of KTEC insertion

  Total number of injections until successful KTEC insertion.

  within day 3

Secondary Outcomes (1)

• success rate of the procedure.

  within day 3

Other Outcomes (8)

• pain evaluation

  within day 3

• number of insertion attempts in cases of previous failure

  within day 3

• procedure time

  within day 3

Study Arms (2)

4 hand

EXPERIMENTAL

At D1, on the first attempt, the KTEC will be inserted by an I(P)DE/physician pair served by the nurse in charge of the child (whatever their level of experience) using the standard method, with no limit to the number of injections. At D2, if KTEC insertion fails at D1, a second attempt will be made, respecting the newborn's randomization arm. This second attempt must be carried out by an I(P)DE/doctor pair, with the nurse having a minimum of three years' seniority in a neonatal intensive care unit, and whose expertise will ensure successful insertion, with the number of injections limited to five. At D3, in the event of a further failure at D2, a third and final attempt will be made by a senior doctor, with no limit on the number of injections (to encourage success), in line with current department practice. Translated with DeepL.com (free version)

Procedure: catheter insertion

2 hand

ACTIVE COMPARATOR

At D1, on the first attempt, the KTEC will be inserted by the doctor alone (junior or senior, depending on availability), assisted by the nurse responsible for the child, using the standard method, with no limit on the number of injections. On D2, if KTEC insertion fails on D1, a second attempt will be made, respecting the newborn's randomization arm. This second attempt must be made by a senior doctor in the department, whose expertise will help ensure successful insertion, with the number of injections limited to five. At D3, in the event of a further failure at D2, a third and final attempt will be made by another senior doctor, with no limit on the number of injections (to encourage success), in line with the department's current practice. Translated with DeepL.com (free version)

Procedure: catheter insertion

Interventions

catheter insertion PROCEDURE

success of catheter insertion

2 hand; 4 hand

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Parents under guardianship or curatorship, deprived of liberty or under court protection
• Parents who do not speak or understand French
• Newborn born under X

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Premature Birth; Pain

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Nathalie SATURNIN LENOBLE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 6, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 4, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)