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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813326
Acronym
IPICAVE
Enrollment
96
Registered
2025-02-06
Start date
2025-07-01
Completion date
2027-02-04
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

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

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.

Interventions

success of catheter insertion

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Successfull of KTEC insertionwithin day 3Total number of injections until successful KTEC insertion.

Secondary

MeasureTime frameDescription
success rate of the procedure.within day 3Success or failure of KTEC insertion.

Other

MeasureTime frameDescription
procedure timewithin day 3procedure time in minutes
Study the factors associated with the total number of biteswithin day 3number of bites according to the occurrence or non-occurrence of state of consciousness (awake or sedated newborn)
pain evaluationwithin day 3Average and maximum pain during injections, measured by hetero-evaluation scales
hemoglobin levelswithin day 3Percentage change in hemoglobin between two consecutive days (dependent variable) and number of injections performed between the two hemoglobin measurements (independent variable)
Study factors associated with average and maximum pain in newbornswithin day 3average and maximum pain according to state of gestational age (in weeks of amenorrhea: ˂29 , 29 to 32, 33 to 36, 37 to 42, and \>42)
number of insertion attempts in cases of previous failurewithin day 3Total number of previous unsuccessful placement attempts

Countries

France

Contacts

Primary ContactLise Laclautre
promo_interne_drci@chu-clermontferrand.fr334.73.754.963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026