Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light

NCT05831605 | Completed

• 2 other identifiers: D20170121ID-RCB
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venipuncture

Keywords

Venipuncture; Near Infrared Light; Paediatric venepuncture; Venous blood sampling

Outcome Measures

Primary Outcomes (1)

• 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.

  at day 0

Secondary Outcomes (3)

• Successful venepuncture duration

  at day 0

• Pain evaluation during venipuncture

  at day 0

• Caregivers's opinion

  at day 0

Study Arms (2)

Control group

NO INTERVENTION

Venipuncture without near-infrared light

Experimental group

EXPERIMENTAL

Venipuncture with near-infrared light

Procedure: venipuncture with near-infrared light

Interventions

venipuncture with near-infrared light PROCEDURE

with near-infrared light to locate the veins

Experimental group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Trousseau

Paris, 75012, France

Location

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ricardo CARBAJAL, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 26, 2023
• Study Start: May 17, 2023
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)