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Status:

NOT_YET_RECRUITING

Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly

Lead Sponsor:

Hôpital NOVO

Conditions:

Newborn Morbidity

Eligibility:

All Genders

Phase:

PHASE2

Brief Summary

The aim of this study is to demonstrate, with a good level of evidence, the efficacy, safety and feasibility of placing an umbilical route through Wharton's jelly, in the context of emergency situatio...

Detailed Description

In France, it is estimated that 2 to 4 births per 1000 are complicated by perinatal anoxia. This infrequent event constitutes a vital emergency because, in addition to death, the consequences, particu...

Eligibility Criteria

Inclusion

  • Inclusion Criteria :
  • Full-term newborn (≥ 37 SA)
  • Newborn for whom a resuscitation decision has been taken.
  • Newborn in circulatory arrest, or in profound bradycardia \< 60 bpm, requiring an injection of adrenaline in the delivery room, the indication being established in accordance with the recommendations of the European Resuscitation Council 2021, after completion of the first stages of cardiopulmonary resuscitation, including the establishment of effective ventilation
  • Newborn beneficiary of a social security scheme or entitled person.
  • Non-inclusion Criteria :
  • Newborn with known heart defects or other potentially lethal defects
  • Presence of a pre-existing access route
  • Paediatric resuscitator not trained to the UVW procedure
  • Twins born in circulatory arrest and requiring simultaneous management

Exclusion

    Key Trial Info

    Start Date :

    September 1 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 1 2027

    Estimated Enrollment :

    26 Patients enrolled

    Trial Details

    Trial ID

    NCT06915467

    Start Date

    September 1 2025

    End Date

    October 1 2027

    Last Update

    September 9 2025

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Paediatric resuscitation and neonatal medicine department- Centre Hospitalier Universitaire Amiens-Picardie

    Amiens, France, 80054

    2

    Neonatal medicine department - Hôpital Louis Mourier

    Colombes, France, 92700

    3

    Neonatal medicine and resuscitation department - Centre hospitalier intercommunal de Poissy Saint-Germain-en-Laye - Poissy site

    Poissy, France, 78300

    4

    Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine

    Saint-Denis, France, 93200