New inhaled therapy could help preterm infants breathe easier

NCT ID NCT06776783

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Christus Children's Hospital

    RECRUITING

    San Antonio, Texas, 78207, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Goryeb Children's Hospital

    RECRUITING

    Morristown, New Jersey, 07960, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Jacobs Medical Center

    RECRUITING

    La Jolla, California, 92037, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Maria Farreri Children's Hospital

    RECRUITING

    Valhalla, New York, 10595, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Memorial Hospital of South Bend

    RECRUITING

    South Bend, Indiana, 46601, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

    Contact Email: •••••@•••••

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

    RECRUITING

    New York, New York, 10032, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • UF Health Jacksonville

    RECRUITING

    Jacksonville, Florida, 32209, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University of Virginia School of Medicine

    RECRUITING

    Charlottesville, Virginia, 22903, United States

    Contact Email: •••••@•••••

  • WVU Medicine Children's Hospital

    RECRUITING

    Morgantown, West Virginia, 26506, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••