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

Last updated: May 1, 2024
Sponsor: ONY
Overall Status: Completed

Phase

3

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

Solarys

Aerosolized Calfactant

Clinical Study ID

NCT03058666
Aero-02
  • Ages 1-24
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

RDS Patients

  1. NICU patient, ≥1hour of age and <24 hours of age.

  2. Clinical diagnosis of RDS, with or without chest X-ray data.

  3. Inspired oxygen ≥21% to maintain adequate oxygen saturation.

  4. Not intubated

  5. Requiring:

  6. nasal continuous positive airway pressure (nCPAP).

Exclusion

Exclusion Criteria:

  1. Congenital anomaly limiting care options or requiring early surgery.

  2. Cardiopulmonary decompensation.

  3. hypotension with metabolic acidosis (base excess < -10 meq/l).

  4. Oxygen saturations < 88% at start of aerosolization.

  5. PaCO2 ≥ 60 mmHg at start of aerosolization.

  6. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.

  7. Acute hypoxic encephalopathy with or without seizures.

Study Design

Total Participants: 477
Treatment Group(s): 2
Primary Treatment: Solarys
Phase: 3
Study Start date:
March 29, 2017
Estimated Completion Date:
July 31, 2018

Study Description

Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.

Connect with a study center

  • USA Children's & Women's Hospital

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California 92123
    United States

    Site Not Available

  • Wolfson Children's

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Baptist Hospital of Miami

    Miami, Florida 33176
    United States

    Site Not Available

  • Adventist Healthcare System, Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Johns Hopkins All Children's Hospital

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • University of South Florida, Tampa general

    Tampa, Florida 33606
    United States

    Site Not Available

  • Columbus Regional Hospital

    Columbus, Georgia 31904
    United States

    Site Not Available

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Wesley Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Kentucky Children's Hospital, University of Kentucky Medical Center

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Children's Hospital and Clinics

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Children's Hospital Minnesota

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Sisters of Charity Hospital

    Buffalo, New York 14214
    United States

    Site Not Available

  • Pitt County Memorial Hospital

    Greenville, North Carolina 27835
    United States

    Site Not Available

  • The Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Jackson-Madison County General Hospital

    Jackson, Tennessee 38301
    United States

    Site Not Available

  • Vanderbilt university Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • North central Baptist Hospital

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Timpanogos Regional Medical Center

    Orem, Utah 84057
    United States

    Site Not Available

  • Utah Valley Hospital

    Provo, Utah 84604
    United States

    Site Not Available

  • University of Virgina Medical Center

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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