Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Finding the right dose: how morphine and midazolam affect ventilated newborns

NCT ID NCT05371886

Knowledge-focused Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study looks at how morphine, given alone or with midazolam, works in newborns who need breathing machines in intensive care. Researchers will monitor 180 infants to find the dose that provides comfort without over-sedation. The goal is to improve pain management for these fragile patients.

What this could mean

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

Active substance
morphine and midazolam
What this could lead to
If successful, this could help doctors determine the safest and most effective doses of these sedatives for newborns on breathing machines.
What could go wrong
This is an observational study, not a treatment trial. It aims to gather data, not test a new therapy, so direct patient benefits are uncertain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

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

Started

Apr 2023

Expected to finish

May 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

20 to 45 weeks

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: * Neonates \< 45 weeks of corrected gestational age * Hospitalized in a Neonatal Intensive Care Unit * Undergoing mechanical ventilation * Patients that receive morphine alone or morphine and midazolam as continuous infusion * Affiliated to a social security system Exclusion Criteria: * Current weight \< 600g * Neonates under palliative care * Therapeutic hypothermia for perinatal anoxia * Neonates who underwent a surgical procedure during the past 72 hours * Neonates receiving concomitantly a paralytic or another drug for sedation or analgesia other than morphine or midazolam (except for paracetamol/acetaminophen) * Parents refusing that their child participate

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Mechanical ventilation in neonates are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

agnosia

As listed by the trial registrant

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

Mechanical ventilation in neonates Sedation complication

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

  • CH SUD Francilien

    RECRUITING

    Corbeil-Essonnes, 91100, France

  • CHI Créteil

    RECRUITING

    Créteil, 94000, France

  • CHRU Morvan

    RECRUITING

    Brest, 29609, France

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU Tours

    RECRUITING

    Tours, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.