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New method aims to help premature babies breathe easier without a breathing tube

NCT ID NCT07176117

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study tests whether giving surfactant (a natural substance that helps lungs stay open) through a small airway device placed above the vocal cords, along with standard breathing support (CPAP), is better than CPAP alone for late preterm and early term infants with respiratory distress. About 422 newborns will be enrolled. The goal is to see if this less invasive approach reduces complications and hospital stays.

What this could mean

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

Active substance
surfactant
What this could lead to
If successful, this could provide a safer, less invasive way to treat breathing problems in newborns, potentially reducing complications and hospital stays.
What could go wrong
This is a single-center study, and results may not apply to all hospitals. The procedure still carries risks like any airway device, and the benefit over standard CPAP alone is not yet proven.

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

About 422 people

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

Started

Nov 2025

Expected to finish

Jun 2031

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

33 to 38 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: * Newborns 33-38+6 weeks gestation at birth * ≤ 6 hours old * Respiratory Distress: \[Silverman Andersen Score (SAS) ≥ 5, or Respiratory Severity Score (RSS) ≥ 1.25\] * Clinical decision for non-invasive respiratory support * Written parental consent Exclusion Criteria: * Surrogate deliveries * Major congenital or chromosomal anomalies * Prior intubation or receipt of surfactant * Known or suspected hypoxic ischemic encephalopathy (HIE) * Known or suspected neuromuscular disorder * Unanticipated survival

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Conditions

The condition(s) this trial relates to.

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.

Respiratory distress syndrome (neonatal) Surfactant

How to take part

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

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Sharp Chula Vista Medical Center

    Chula Vista, California, 91911, United States

  • Sharp Grossmont Hospital

    La Mesa, California, 91942, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

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