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Could a common asthma drug help newborns breathe easier?

NCT ID NCT05527704

Symptom relief Sponsor: Medical University of Warsaw 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether inhaled salbutamol, a drug used for asthma, can help newborns with transient tachypnoea (rapid breathing after birth). About 608 babies born between 32 and 42 weeks will receive either salbutamol or a placebo. The goal is to see if the drug reduces the need for breathing support and prevents complications like persistent pulmonary hypertension.

What this could mean

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

Active substance
salbutamol (also known as albuterol)
What this could lead to
If it works, this could provide a safe, inhaled treatment to help newborns with rapid breathing recover faster and need less breathing support.
What could go wrong
This is a late-stage trial, but the effect may be modest or not better than placebo. Side effects like rapid heart rate or low potassium are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 608 people

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

Started

Dec 2021

Expected to finish

Sep 2026

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

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: 1. Gestational age at birth between 32 and 42 weeks. 2. Respiratory disorders (tachypnea and expiratory grunting) lasting longer than 15 minutes after birth, or present for at least 15 minutes in the first six hrs of life, or a need for non-invasive respiratory support between birth and six hrs of life. 3. Available chest radiographs obtained within six hrs after birth. 4. Available parameters of the acid-base balance (blood pH, partial pressure of O2 and CO2, base excess) and blood serum ionogram for Na+, K+, Ca2+ evaluated in the umbilical cord blood sample. Exclusion Criteria: 1. Need for intubation directly after birth or perinatal asphyxia, defined as abnormal acid-base parameters detected in an umbilical cord blood sample (pH \<7.0 or base excess \< -14 mmol/L). 2. Multiple apnea-brady that require immediate intubation before a trial of NIV 3. Age \>24 h. 4. Meconium aspiration syndrome. 5. Air leak syndrome. 6. Congenital heart disease. 7. Congenital diaphragmatic hernia. 8. Other severe congenital malformations and genetic disorders (diagnosed before and after birth) associated with increased risk of respiratory failure. 9. The need for a surfactant administration immediately after birth, regardless of the method of its administration (respiratory distress syndrome - RDS)

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Conditions

The condition(s) this trial relates to.

respiratory failure TTN-related myopathy persistent fetal circulation syndrome prevention target

As listed by the trial registrant

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

PPHN Respiratory failure TTN

Contacts and locations

Locations

  • Medical University of Warsaw

    Warsaw, Poland

More trials for these conditions

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