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Could a muscle relaxant make newborn intubation safer?

NCT ID NCT07650552

Symptom relief Sponsor: UEA - Universidade Do Estado Do Amazonas 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether adding a muscle relaxant (rocuronium) to standard painkiller (fentanyl) helps doctors place breathing tubes in newborns on the first try, without causing dangerous drops in oxygen or heart rate. About 102 premature or sick babies in a Brazilian NICU will take part. The goal is to improve a common procedure that currently fails about half the time.

What this could mean

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

Active substance
rocuronium (a muscle relaxant) and fentanyl (a painkiller)
What this could lead to
If it works, this could make breathing tube placement safer and more successful for fragile newborns, reducing complications.
What could go wrong
This is a small, early-phase trial (102 babies) in a single hospital, so results may not apply everywhere. Muscle relaxants carry risks like prolonged paralysis, though a reversal drug is available.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 102 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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

1 minute to 28 days

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: * Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age \<44 weeks * Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy) * Informed consent signed by legal guardians Exclusion Criteria: * Upper airway malformations * Use of neuromuscular blocking agent in the 24 hours prior to enrollment * Known hypersensitivity to fentanyl or rocuronium * Severe hemodynamic instability (ongoing shock) * Anticipated difficult airway (micrognathia, cleft palate, or similar) * Cyanotic congenital heart disease with critical instability * Neonatal abstinence syndrome * Concurrent enrollment in another interventional clinical trial

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Conditions

The condition(s) this trial relates to.

Apnea apnea of prematurity newborn respiratory distress syndrome Premature Birth Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Apnea of prematurity Infant, premature Intubation, intratracheal Respiratory distress syndrome, newborn

How to take part

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

  1. The places running it

    1 site. 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

  • Maternidade Ana Braga - UTI Neonatal

    Manaus, Amazonas, 69057000, Brazil

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