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Gentler lung treatment may help preterm babies avoid breathing tubes

NCT ID NCT04209946

Disease control Sponsor: Sharp HealthCare 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 180 premature babies born between 24 and 30 weeks to see if giving lung medication (surfactant) through a thin tube (LISA method) could reduce the need for a breathing tube in the first three days of life, compared to standard CPAP alone. The goal was to find a gentler way to support breathing and avoid more invasive procedures. Results will help doctors choose the best approach for these fragile infants.

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

180 people

The number who actually took part.

Started

Jan 2020

Finished

Nov 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

24 to 29 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: * Premature infants born at 24 to 29+6 weeks gestation * Informed consent obtained (antenatal) * Infant is spontaneously breathing on CPAP of 5-8 cmH2O and maintaining a normal heart rate (HR\>100 Bpm) Exclusion Criteria: * Declined consent * Infants with known congenital anomalies * Unstable immediately after birth, requiring intubation in the delivery room

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome newborn respiratory distress syndrome Premature Birth Pulmonary Atelectasis respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Premature lungs Respiratory distress syndrome Surfactant deficiency syndrome neonatal

Contacts and locations

Locations

  • Loma Linda Medical Center

    Loma Linda, California, 92350, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

  • University of California, Irvine

    Irvine, California, 92868, United States

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