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Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

NCT03582930 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2023-11-07

No results posted yet for this study

Summary

Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS). Currently, such therapy requires instillation of a liquid suspension into the trachea through an endotracheal tube. Endotracheal intubations have undesirable adverse effects on fragile premature infants. Instilling surfactant as a liquid suspension into the lung is associated with adverse events due to interruption of breathing in patients who already have respiratory insufficiency. This treatment protocol is expanded access that offers the opportunity for patients to receive aerosolized Infasurf prior to FDA acting on ONY Biotech's application for approval for commercial marketing of aerosolized Infasurf.

Conditions

  • Neonatal Respiratory Distress

Interventions

COMBINATION_PRODUCT

Infasurf Aero

Aerosolization of Infasurf administered to premature babies suffering from RDS. Successful administration of Infasurf by aerosolization will provide two important benefits for patients. (1) endotracheal intubation may be able to be avoided in some patients, and (2) the adverse events at instillation due to filling the airway with liquid and interrupting breathing may be diminished or abolished.

Sponsors & Collaborators

  • ONY

    lead INDUSTRY

Principal Investigators

  • Jim Cummings, MD · Albany Medical College

Eligibility

Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582930 on ClinicalTrials.gov