New inhaled therapy could help preterm infants breathe easier

NCT ID NCT06776783

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

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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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

Contacts and locations

Show contact details

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

More trials for these conditions

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