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Could pain relief make a lifesaving breathing procedure safer for preterm infants?

NCT ID NCT05065424

Symptom relief Sponsor: University of Texas Southwestern Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether giving two medicines (atropine and fentanyl) before a less invasive breathing treatment helps preterm babies have fewer dangerous drops in heart rate and oxygen levels. Fifty-eight babies born at 29 weeks or later took part. The goal is to see if premedication makes the procedure safer and more comfortable.

What this could mean

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

Active substance
atropine and fentanyl
What this could lead to
If it works, this could make a common breathing procedure safer and less stressful for preterm babies.
What could go wrong
This is a small, single-center trial with only 58 babies, so results may not apply widely. The drugs themselves can cause side effects like slowed breathing.

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

58 people

The number who actually took part.

Started

Apr 2022

Finished

Mar 2026

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

0 to 72 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: * Infants ≥29 weeks gestational age initiated on CPAP in the delivery room or upon admission who require ≥0.25 FiO2. Exclusion Criteria: * Infants requiring intubation prior to surfactant therapy * Infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies) * Infants born to mothers with known opioid addiction or in a methadone treatment program * Maternal COVID19 infection (RT-PCR positive) within two weeks prior to delivery

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome respiratory distress syndrome in premature infants Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Respiratory distress syndrome, newborn

Contacts and locations

Locations

  • Parkland Health and Hospital System

    Dallas, Texas, 75390, United States

More trials for these conditions

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