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NCT Number: NCT06813326

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

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.

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Key information

Conditions

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

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location contact

Lise LACLAUTRE

CONTACT

[email protected]

+33473754963

Nathalie SATURNIN LENOBLE

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

catheter insertion

Procedure

success of catheter insertion

Primary outcomes

  1. Successfull of KTEC insertion

    Time frame: within day 3

    Total number of injections until successful KTEC insertion.

Secondary outcomes

  1. success rate of the procedure.

    Time frame: within day 3

    Success or failure of KTEC insertion.

Other outcomes

  1. pain evaluation

    Time frame: within day 3

    Average and maximum pain during injections, measured by hetero-evaluation scales

  2. number of insertion attempts in cases of previous failure

    Time frame: within day 3

    Total number of previous unsuccessful placement attempts

  3. procedure time

    Time frame: within day 3

    procedure time in minutes

  4. Study the factors associated with the total number of bites

    Time frame: within day 3

    number of bites according to the occurrence or non-occurrence of state of consciousness (awake or sedated newborn)

  5. Study factors associated with average and maximum pain in newborns

    Time frame: within day 3

    average 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)

  6. hemoglobin levels

    Time frame: within day 3

    Percentage change in hemoglobin between two consecutive days (dependent variable) and number of injections performed between the two hemoglobin measurements (independent variable)

  7. Study the factors associated with the total number of bites

    Time frame: within day 3

    number of bites according to catheter type (Premicath, Epicutaneocave, Nutriline twinflow)

  8. Study factors associated with average and maximum pain in newborns

    Time frame: within day 3

    average and maximum pain according to insertion site (left/right upper limb, left/right lower limb, skull)

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: IPICAVE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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