VenipunctureALPIVEINENCT05831605
Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light
A study testing venipuncture with near-infrared light in people with Venipuncture, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine whether the act of venipuncture is more successful on the first attempt using near infrared light compared to a standard puncture on children or newborn whose venous access is considered difficult due to lack of visibility of the veins. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Venipuncture
- What is being tested?
- venipuncture with near-infrared light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2023to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any child aged at most 44 weeks + 6 days of corrected term hospitalized in neonatal intensive care and neonatology with a medical prescription for a venous blood sample or for insertion of a peripheral venous line and with visibility and palpability of the vein under 5mm
- OR
- Any child under the age of 18 in the emergency room with a prescription for a blood test or for insertion of a peripheral venous line and with visibility and palpability of the vein under 5mm
- One parent agreed on their child participation in this study.
- Patient with health insurance
Who cannot join
- Vital emergency which needs a venous route instalment
- Parental refusal
- Parents who do not speak French
- Patient who has already been included in the study
- Blood sample taken by a medical student or a nursing student or childcare nurse student.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the act of venipuncture is more successful on the first attempt using near infrared light compared to a standard puncture on children or newborn whose venous access is considered difficult due to lack of visibility of the veins.
Read the detailed description
This trial aims to evaluate the act of venipuncture with or without the near-infrared light device for any children requiring a venipuncture for a blood sample or for insertion of peripheral venous line in neonatal intensive care and neonatology, and in pediatric emergencies.
For any eligible patient, at least one parent will be approached by a member of the medical or paramedical team trained on the protocol to explain the study to him/her and to be able to include the child during the next venous blood sampling or the insertion of a venous line. In case the parent agrees on the child's participation, the investigator is in charge of obtaining an informed consent.
During the next venous blood sampling or the insertion of a venous line, the nurse responsible for the patient:
- Takes the next consecutively numbered randomization envelope from the room intended for this purpose. This envelope is opaque and contains the randomization group in which the child is assigned (near infrared light or standard technique)
- Takes a study observation book located in the room intended for this purpose.
- Once the nurse is ready to do the venipuncture and before having identified the vein to be punctured, he/she opens the envelope to find out whether or not near infrared light will be used for spotting the vein to be punctured while the person (caregiver or nurse) who will help him during the procedure is present.
- Venous blood sampling or insertion of a venous line according to the technique indicated by the randomization (near infrared light or standard technique) for the first attempt at venipuncture.
- If the first venipuncture attempt fails, the nurse can chose to carry out the 2nd or 3rd attempt with or without near infrared light. Only the first 3 attempts progress will be recorded in the observation book.
- When the venous blood drawing or the insertion of a venous line is over, whether it is successful or not, the assistant present during the procedure completes the observation book on the sampling part.
- The notebook and the envelope used are stored in the room intended for this purpose.
To avoid device-related bias, the AccuVein® AV 400 (CE 0086 marking) was chosen. This device uses near infrared light to detect superficial veins under the skin and then projects an image of these veins onto the skin surface, exactly above the veins. The device will be held between 10 and 20 cm perpendicular to the skin, because at this distance the projected image corresponds to the actual size of the veins located below the skin. It will be either attached to an articulated arm in order to free the operator's hands to perform the procedure, or held by an assistant above the venipuncture site. The assistant can reorient the device during the procedure. The light from the AccuVein® device should not be aimed at the child's eyes. In neonatal intensive care and neonatology, during any use, the newborn's eyes will be covered during the procedure's implementation.
- Conditions
- Venipuncture
- Being tested
- venipuncture with near-infrared light
- Keywords
- Venipuncture, Near Infrared Light, Paediatric venepuncture, Venous blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venipuncture with near-infrared lightProcedure or surgery
with near-infrared light to locate the veins
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Venipuncture without near-infrared light |
| Experimental group | Experimental | Venipuncture with near-infrared light Receives: Procedure: venipuncture with near-infrared light |
What is being measured
The primary outcome is the main question the study is designed to answer.
First venipuncture attempt
Obtention 0.5 ml of blood injection of 1.5 ml of physiological serum without extravasation after the first blood sampling attempt or the first attempt of a peripheral venous line.
Measured: at day 0
Secondary outcomes (3)
Successful venepuncture duration
Duration from application of tourniquet to obtention of 0.5 ml of blood After the first blood sampling attempt or the first attempt of a peripheral venous line at most after the 3rd venepuncture attempt
Measured: at day 0
Pain evaluation during venipuncture
Using FLACC or DAN (acute pain of the new-born) scale (score 0 to 10, 10 is most painful) at most after the 3rd venepuncture attempt
Measured: at day 0
Caregivers's opinion
Opinion of caregivers on the ease of use, effectiveness and their general satisfaction, using a small questionary (very unsatisfied, unsatisfied, satisfied, very satisfied) at most after the 3rd venepuncture attempt
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start17 May 2023
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VenipunctureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Ricardo CARBAJAL, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831605
- Sponsor's protocol ID
- D20170121
- Other IDs
- ID-RCB
- Acronym
- ALPIVEINE
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2023
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light
- ClinicalTrials.gov ID
- NCT05831605
- Acronym / sponsor ID
- ALPIVEINE / D20170121
- Conditions
- Venipuncture
- Keywords
- Venipuncture, Near Infrared Light, Paediatric venepuncture, Venous blood sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 17 May 2023 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 26 Apr 2023 (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.
The purpose of this study is to determine whether the act of venipuncture is more successful on the first attempt using near infrared light compared to a standard puncture on children or newborn whose venous access is considered difficult due to lack of visibility of the veins.
Detailed description
This trial aims to evaluate the act of venipuncture with or without the near-infrared light device for any children requiring a venipuncture for a blood sample or for insertion of peripheral venous line in neonatal intensive care and neonatology, and in pediatric emergencies.
For any eligible patient, at least one parent will be approached by a member of the medical or paramedical team trained on the protocol to explain the study to him/her and to be able to include the child during the next venous blood sampling or the insertion of a venous line. In case the parent agrees on the child's participation, the investigator is in charge of obtaining an informed consent.
During the next venous blood sampling or the insertion of a venous line, the nurse responsible for the patient:
- Takes the next consecutively numbered randomization envelope from the room intended for this purpose. This envelope is opaque and contains the randomization group in which the child is assigned (near infrared light or standard technique)
- Takes a study observation book located in the room intended for this purpose.
- Once the nurse is ready to do the venipuncture and before having identified the vein to be punctured, he/she opens the envelope to find out whether or not near infrared light will be used for spotting the vein to be punctured while the person (caregiver or nurse) who will help him during the procedure is present.
- Venous blood sampling or insertion of a venous line according to the technique indicated by the randomization (near infrared light or standard technique) for the first attempt at venipuncture.
- If the first venipuncture attempt fails, the nurse can chose to carry out the 2nd or 3rd attempt with or without near infrared light. Only the first 3 attempts progress will be recorded in the observation book.
- When the venous blood drawing or the insertion of a venous line is over, whether it is successful or not, the assistant present during the procedure completes the observation book on the sampling part.
- The notebook and the envelope used are stored in the room intended for this purpose.
To avoid device-related bias, the AccuVein® AV 400 (CE 0086 marking) was chosen. This device uses near infrared light to detect superficial veins under the skin and then projects an image of these veins onto the skin surface, exactly above the veins. The device will be held between 10 and 20 cm perpendicular to the skin, because at this distance the projected image corresponds to the actual size of the veins located below the skin. It will be either attached to an articulated arm in order to free the operator's hands to perform the procedure, or held by an assistant above the venipuncture site. The assistant can reorient the device during the procedure. The light from the AccuVein® device should not be aimed at the child's eyes. In neonatal intensive care and neonatology, during any use, the newborn's eyes will be covered during the procedure's implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Venipuncture without near-infrared light |
| Experimental group | Experimental | Procedure: venipuncture with near-infrared lightVenipuncture with near-infrared light |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Any child aged at most 44 weeks + 6 days of corrected term hospitalized in neonatal intensive care and neonatology with a medical prescription for a venous blood sample or for insertion of a peripheral venous line and with visibility and palpability of the vein under 5mm
- OR
- Any child under the age of 18 in the emergency room with a prescription for a blood test or for insertion of a peripheral venous line and with visibility and palpability of the vein under 5mm
- One parent agreed on their child participation in this study.
- Patient with health insurance
Key exclusion criteria (5 listed)
- Vital emergency which needs a venous route instalment
- Parental refusal
- Parents who do not speak French
- Patient who has already been included in the study
- Blood sample taken by a medical student or a nursing student or childcare nurse student.
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 |
|---|---|---|
| venipuncture with near-infrared lightwith near-infrared light to locate the veins | Procedure or surgery | Experimental group |
Primary outcome
First venipuncture attempt
Time frame: at day 0
Obtention 0.5 ml of blood injection of 1.5 ml of physiological serum without extravasation after the first blood sampling attempt or the first attempt of a peripheral venous line.
3 secondary outcomes
Successful venepuncture duration
Time frame: at day 0
Pain evaluation during venipuncture
Time frame: at day 0
Caregivers's opinion
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ricardo CARBAJAL, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venipuncture with near-infrared light in people with Venipuncture, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 23 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First venipuncture attempt (time frame: at day 0). 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 23 Mar 2026.