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New inhaled therapy could help preterm infants breathe easier

NCT ID NCT06776783

Disease control Sponsor: Aerogen Pharma Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a new inhaled medication called APC-0101 in 520 premature babies born between 26 and 33 weeks who have respiratory distress syndrome. The drug is a surfactant that helps keep tiny air sacs in the lungs open. Some babies receive the active drug through a special mask, while others get a sham treatment. The main goal is to see if APC-0101 reduces the need for more invasive breathing support.

What this could mean

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

Active substance
APC-0101 (inhaled surfactant)
What this could lead to
If successful, this could offer a gentler, non-invasive way to help preterm babies breathe, reducing the need for more invasive treatments.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. The sham-controlled design means some babies receive no active drug, and long-term effects are still being studied.

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 520 people

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

Started

Sep 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 hour 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. Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery) 2. Gestational age at birth of 26 through 33 weeks PMA 3. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve) 4. Birth weight ≤ 2000 grams 5. Post-natal age 1 to 24 hours at randomization 6. On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2). 7. FiO2 ≥ 0.24 at randomization 8. nCPAP or mPaw ≥ 6 cm H2O at randomization 9. Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization Exclusion Criteria: 1. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\> 2 liters per minute \[LPM\]) at the time of randomization 2. Prior instillation of surfactant 3. Premature rupture of membranes (PROM) occurring \> 14 days before birth 4. Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy) 5. Pneumothorax 6. Other etiologies of respiratory distress 7. Enrollment in another interventional study with similar efficacy endpoints 8. Apgar score at 5 min of 0-3 9. Prior cardiopulmonary resuscitation (CPR) or epinephrine 10. Base Deficit \> 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization. 11. Partial pressure of carbon dioxide (PaCO2) \> 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. 12. Triplet or higher order multiple birth

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Pre-term infants Respiratory distress syndrome

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Christus Children's Hospital

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Goryeb Children's Hospital

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Jacobs Medical Center

    RECRUITING

    La Jolla, California, 92037, United States

    Contact Email: •••••@•••••

  • Maria Farreri Children's Hospital

    RECRUITING

    Valhalla, New York, 10595, United States

  • Memorial Hospital of South Bend

    RECRUITING

    South Bend, Indiana, 46601, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • The Trustees of Columbia University in the City of New York

    RECRUITING

    New York, New York, 10032, United States

  • UF Health Jacksonville

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Virginia School of Medicine

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • WVU Medicine Children's Hospital

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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