InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

PHASE3RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

January 1, 2026

Study Completion Date

April 1, 2026

Conditions
Respiratory Distress Syndrome (Neonatal)Intubation ComplicationDeath; Neonatal
Interventions
COMBINATION_PRODUCT

Infasurf Aero™

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

Trial Locations (10)

14214

RECRUITING

Sisters of Charity Hospital, Buffalo

32209

RECRUITING

University of Florida -Jacksonville, Jacksonville

38301

RECRUITING

Western TN- Jackson-Madison County General Hospital, Jackson

53715

RECRUITING

Unity Point Meriter, Madison

84604

RECRUITING

Utah Valley Hospital, Provo

85013

RECRUITING

St. Josephs Hospital and Medical Center, Phoenix

85016

RECRUITING

Phoenix Children's, Phoenix

92123

RECRUITING

Sharp Mary Birch Hospital for Women & Newborns, San Diego

96826

RECRUITING

Kapi'olani Medical Center for Women & Children, Honolulu

07753

RECRUITING

Jersey Shore University Medical Center, Neptune City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Avania

INDUSTRY

lead

ONY

INDUSTRY