RecruitingPhase 3NCT05960929

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial

Sponsor

ONY

Enrollment

220 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Intubation Complication Respiratory Distress Syndrome (Neonatal)Death; Neonatal

Summary

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

Eligibility

Min Age: 29 WeeksMax Age: 36 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Infasurf Aero™ for people with death; neonatal, intubation complication, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 29 Weeks to 36 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTInfasurf Aero™

A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

Locations(10)

St. Josephs Hospital and Medical Center

Phoenix, Arizona, United States

Phoenix Children's

Phoenix, Arizona, United States

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

University of Florida -Jacksonville

Jacksonville, Florida, United States

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Sisters of Charity Hospital

Buffalo, New York, United States

Western TN- Jackson-Madison County General Hospital

Jackson, Tennessee, United States

Utah Valley Hospital

Provo, Utah, United States

Unity Point Meriter

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05960929

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