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Could a new sedative protect newborn brains during cooling?

NCT ID NCT04772222

Symptom relief Sponsor: University of Utah 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a drug called dexmedetomidine in 50 newborns with brain injury who were undergoing cooling therapy. The goal was to see if it could provide sedation and pain relief as well as morphine, but with fewer risks. Researchers measured safety and drug levels in the blood to prepare for a larger future trial.

What this could mean

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

Active substance
Dexmedetomidine (a sedative and pain reliever that does not slow breathing)
What this could lead to
If it works, this could point toward a safer way to sedate newborns with brain injury during cooling therapy, reducing reliance on opioids.
What could go wrong
This is a small, early-phase trial with only 50 infants, so results may not apply broadly. The drug's safety and effectiveness in this specific group are still unproven.

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

50 people

The number who actually took part.

Started

Jun 2022

Finished

Dec 2025

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

Up to 24 hours

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 ≥36 weeks' gestational age diagnosed with moderate-to-severe neonatal encephalopathy and treated with TH (target temperature 33.5°C) for a planned duration of 72 h. * Infants requiring sedation and/or treatment to prevent shivering during TH as assessed by the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores and a modified Bedside Shivering Assessment Scale. * Informed consent document approved by the Institutional Review Board (IRB) obtained prior to randomization Exclusion Criteria: * Known chromosomal anomalies * Cyanotic congenital heart defects * Redirection of care being considered because of moribund condition, or a decision made to withhold full support

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia Pain perinatal asphyxia

As listed by the trial registrant

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

Hypoxic-ischemic encephalopathy Pain

Contacts and locations

Locations

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • McKay-Dee Hospital

    Ogden, Utah, 84403, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • University of Utah Health

    Salt Lake City, Utah, 84132, United States

  • Utah Valley Hospital

    Provo, Utah, 84604, United States

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