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New technique could speed up lifesaving care for newborns in crisis

NCT ID NCT06915467

Disease control Sponsor: Hôpital NOVO Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study tests a new way to place an emergency IV line through the umbilical cord in newborns who need urgent resuscitation. The procedure aims to deliver adrenaline faster than the standard method. Researchers will enroll 26 full-term babies to see if the new technique can restore a normal heart rate within 90 seconds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
umbilical vein catheterization through Wharton's jelly procedure
What this could lead to
If it works, this could provide a quicker, more reliable emergency access for life-saving drugs in newborns, potentially improving resuscitation outcomes.
What could go wrong
This is a small, early-phase study with only 26 participants, so results may not apply broadly. The procedure may fail or take longer than expected, and standard care will be used as backup.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiac arrest

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Newborn morbidity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Neonatal medicine - neonatal resuscitation department - Hôpital Delafontaine

    Saint-Denis, 93200, France

  • Neonatal medicine and resuscitation department - Centre Hospitalier de Troyes

    Troyes, 10000, France

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

    Poissy, 78300, France

  • Neonatal medicine department - Hôpital Louis Mourier

    Colombes, 92700, France

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

    Amiens, 80054, France

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