Premature BirthIPICAVENCT06813326
Interest of Nurse Participation During Epicutaneous-cavity Catheter Placement in Neonatal Intensive Care
A study testing catheter insertion in people with Premature Birth, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- catheter insertion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to 4 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- Parents under guardianship or curatorship, deprived of liberty or under court protection
- Parents who do not speak or understand French
- Newborn born under X
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand
Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Nathalie SATURNIN LENOBLE
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- catheter insertion
- Keywords
- newborn, neonatal intensive care, percutaneous central venous catheter, nurse, pain, shots
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter insertionProcedure or surgery
success of catheter insertion
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfull of KTEC insertion
Total number of injections until successful KTEC insertion.
Measured: within day 3
Secondary outcomes (1)
success rate of the procedure.
Success or failure of KTEC insertion.
Measured: within day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion4 Feb 2027 (estimated)
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie SATURNIN LENOBLE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813326
- Sponsor's protocol ID
- AOI 2023 SATURNIN
- Acronym
- IPICAVE
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Nurse Participation During Epicutaneous-cavity Catheter Placement in Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT06813326
- Acronym / sponsor ID
- IPICAVE / AOI 2023 SATURNIN
- Conditions
- Premature Birth
- Keywords
- newborn, neonatal intensive care, percutaneous central venous catheter, nurse, pain, shots
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 4 Feb 2027 (estimated)
- Study completion
- 4 Feb 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 hand | Experimental | Procedure: catheter insertionAt 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) |
| 2 hand | Active comparator | Procedure: catheter insertionAt 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) |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Parents under guardianship or curatorship, deprived of liberty or under court protection
- Parents who do not speak or understand French
- Newborn born under X
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter insertionsuccess of catheter insertion | Procedure or surgery | 2 hand, 4 hand |
Primary outcome
Successfull of KTEC insertion
Time frame: within day 3
Total number of injections until successful KTEC insertion.
1 secondary outcome
success rate of the procedure.
Time frame: within day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
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Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie SATURNIN LENOBLE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter insertion in people with Premature Birth, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successfull of KTEC insertion (time frame: within day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.