Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

Completed · Phase 3

Conditions studied: Respiratory Distress Syndrome

In brief

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Key facts

Study ID

NCT03058666

Run by

ONY

People needed

477

Starts

2017-03-29

Expected to finish

2018-07-31

Last updated by the study team

2024-05-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• RDS Patients
• NICU patient, ≥1hour of age and <24 hours of age.
• Clinical diagnosis of RDS, with or without chest X-ray data.
• Inspired oxygen ≥21% to maintain adequate oxygen saturation.
• Not intubated
• Requiring:
• nasal continuous positive airway pressure (nCPAP).

You may not qualify if…

• Congenital anomaly limiting care options or requiring early surgery.
• Cardiopulmonary decompensation.
• hypotension with metabolic acidosis (base excess < -10 meq/l).
• Oxygen saturations < 88% at start of aerosolization.
• PaCO2 ≥ 60 mmHg at start of aerosolization.
• Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
• Acute hypoxic encephalopathy with or without seizures.

Where it is running

• USA Children's & Women's Hospital — Mobile, Alabama, United States
• Banner - University Medical Center Phoenix — Phoenix, Arizona, United States
• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Adventist Healthcare System, Florida Hospital — Orlando, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• University of South Florida, Tampa general — Tampa, Florida, United States
• Columbus Regional Hospital — Columbus, Georgia, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Kentucky Children's Hospital, University of Kentucky Medical Center — Lexington, Kentucky, United States
• Children's Hospital and Clinics — Minneapolis, Minnesota, United States
• Children's Hospital Minnesota — Saint Paul, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Sisters of Charity Hospital — Buffalo, New York, United States
• Pitt County Memorial Hospital — Greenville, North Carolina, United States
• The Medical University of South Carolina — Charleston, South Carolina, United States
• Jackson-Madison County General Hospital — Jackson, Tennessee, United States
• Vanderbilt university Medical Center — Nashville, Tennessee, United States
• North central Baptist Hospital — San Antonio, Texas, United States
• Timpanogos Regional Medical Center — Orem, Utah, United States
• Utah Valley Hospital — Provo, Utah, United States
• University of Virgina Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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