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New drug could shield preemie lungs from deadly disease

NCT ID NCT06897839

Prevention Sponsor: Airway Therapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tests an investigational drug called zelpultide alfa to see if it can prevent bronchopulmonary dysplasia (BPD), a serious chronic lung disease, in extremely premature babies (born between 22 and 27 weeks). About 366 high-risk infants will receive either the drug or a placebo (air sham) alongside standard care. The goal is to reduce the number of babies who develop severe BPD or die.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 366 people

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

Started

Feb 2025

Expected to finish

Apr 2030

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

0 minutes to 96 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. Born between gestational age (GA) 22 0/7 to 27 6/7 weeks, inclusive. 2. Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactant treatment after birth. 3. Intubated and on invasive mechanical ventilation per SOC. 4. Able to receive the first dose of zelpultide alfa or air-sham at least 15 min after the surfactant administration but within 96 h of birth and within 48 h from the start of invasive mechanical ventilation. Subjects extubated and re-intubated after their pulmonary surfactant dose(s) are eligible as long as the inclusion criteria are met. 5. Informed consent and personal information authorization form signed by the subject's parent(s) or legal guardian(s). Exclusion Criteria: 1. Birth weight \< 400 g or \> 1,500 g. 2. Major apparent congenital abnormalities impacting cardio and pulmonary function identified before randomization, such as, but not limited to: * Clinically relevant Potter-like syndrome and any pulmonary congenital anomalies, * Clinically relevant congenital diaphragmatic hernia, * Omphalocele or gastroschisis, esophageal atresia, * Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot, transposition of the great arteries, etc). 3. Active do no resuscitate (DNR) order in place. 4. History of allergy or sensitivity to any surfactant or any component of zelpultide alfa. 5. Concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of SOC or participation in studies within the last 30 days (or 5 half-lives of an IMP) prior to birth (for the mother) or up to week 36 PMA. 6. Any condition or situation that, in the Investigator's judgement, puts the neonate at significant risk, could confound the study results, or may interfere significantly with the neonate's participation in the study.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia prevention target

As listed by the trial registrant

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

Bronchopulmonary dysplasia

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

    50 sites in 8 countries. 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

  • AP-HP CHU Robert-Debré - Hôpitaux de Paris

    RECRUITING

    Paris, France

  • AP-HP Paris Saclay University - Hôpitaux Antoine-Béclère

    RECRUITING

    Paris, France

  • AP-HP Paris Saclay University Bicêtre Hospital

    RECRUITING

    Paris, France

  • AP-HP University Hospital Cochin - Port Royal

    RECRUITING

    Paris, France

  • Azienda Ospedale Università di Padova

    RECRUITING

    Padova, Italy

  • Bnai Zion Medical Center

    RECRUITING

    Haifa, Israel

  • CHRU Nancy

    RECRUITING

    Nancy, France

  • CHU Lille - Hôpital Jeanne de Flandre

    RECRUITING

    Lille, France

  • CHU Nice

    RECRUITING

    Nice, France

  • CHU de Liege - Hospital de la Citadelle

    RECRUITING

    Liège, Belgium

  • Clinique CHC MontLégia

    RECRUITING

    Liège, Belgium

  • Cliniques Universitaires Saint-Luc

    NOT_YET_RECRUITING

    Brussels, Belgium

  • Clínica y Maternidad Suizo Argentina

    RECRUITING

    Buenos Aires, Argentina

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Italy

  • Gynecological Obstetric Clinical Hospital of Poznan University of Medical Sciences

    RECRUITING

    Poznan, Poland

  • Haddasah medical center

    RECRUITING

    Jerusalem, Israel

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Clínico Universitario de Santiago

    RECRUITING

    Santiago de Compostela, Spain

  • Hospital General Universitario Gregorio Marañón

    RECRUITING

    Madrid, Spain

  • Hospital General Universitario de Alicante Dr. Balmis

    RECRUITING

    Alicante, Spain

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Buenos Aires, Argentina

  • Hospital Regional Universitario de Málaga

    RECRUITING

    Málaga, Spain

  • Hospital Sanatorio de la Trinidad San Isidro

    RECRUITING

    Buenos Aires, Argentina

  • Hospital Sant Joan de Déu

    RECRUITING

    Barcelona, Spain

  • Hospital Universitari Arnau de Vilanova de Lleida

    RECRUITING

    Lleida, Spain

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, Spain

  • Hospital Universitario Austral

    RECRUITING

    Buenos Aires, Argentina

  • Hospital Universitario Cruces - OSI Ezkerraldea-Enkarterri-Cruces

    RECRUITING

    Bilbao, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, Spain

  • Hospital Universitario Puerta del Mar

    RECRUITING

    Cadiz, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Spain

  • Hôpital de Poissy Saint-Germain-en-Laye

    RECRUITING

    Poissy, France

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

    RECRUITING

    Bologna, Italy

  • Istituto Giannina Gaslini

    RECRUITING

    Genova, Italy

  • Medical Faculty of TU Dresden

    NOT_YET_RECRUITING

    Dresden, Germany

  • Ospedale dei Bambini "V. Buzzi"

    RECRUITING

    Milan, Italy

  • Polish Mother's Memorial Hospital - Research Institute in Lodz

    RECRUITING

    Lodz, Poland

  • Rambam Medical Center

    RECRUITING

    Haifa, Israel

  • Shaare-Zedek Medical Center

    RECRUITING

    Jerusalem, Israel

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • University Children's Hospital Regensburg (KUNO)

    RECRUITING

    Regensburg, Germany

  • University Clinical Hospital No. 2 PUM

    NOT_YET_RECRUITING

    Szczecin, Poland

  • University Hospital Wroclaw

    RECRUITING

    Wroclaw, Poland

  • University Hospital in Krakow

    NOT_YET_RECRUITING

    Krakow, Poland

  • Università degli Studi di Napoli Federico II

    RECRUITING

    Naples, Italy

  • Universitätsklinikum Freiburg

    NOT_YET_RECRUITING

    Freiburg im Breisgau, Germany

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, Poland

  • ZAS Middelheim

    RECRUITING

    Antwerp, Belgium

  • Ziv Medical Center

    RECRUITING

    Safed, Israel

More trials for these conditions

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