Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
1 other identifier
interventional
477
1 country
22
Brief Summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2017
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
March 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedResults Posted
Study results publicly available
May 29, 2024
CompletedMay 29, 2024
May 1, 2024
1.2 years
February 16, 2017
November 3, 2023
May 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intubation and Instillation of Liquid Surfactant
Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
72 hours
Secondary Outcomes (2)
Respiratory Support Requirements
28 days
Air Leak
28 days
Study Arms (2)
Aerosolized Calfactant
EXPERIMENTAL1. NICU Patients with a clinical diagnosis of RDS 2. Inspired oxygen ≥21% to maintain adequate oxygen saturation 3. Not Intubated 4. Requiring Nasal continuous positive airway pressure
Usual Care
NO INTERVENTIONThere will be no protocol driven interventions in the usual care group.
Interventions
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ONYlead
Study Sites (22)
USA Children's & Women's Hospital
Mobile, Alabama, 36604, United States
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Adventist Healthcare System, Florida Hospital
Orlando, Florida, 32803, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
University of South Florida, Tampa general
Tampa, Florida, 33606, United States
Columbus Regional Hospital
Columbus, Georgia, 31904, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Kentucky Children's Hospital, University of Kentucky Medical Center
Lexington, Kentucky, 40506, United States
Children's Hospital and Clinics
Minneapolis, Minnesota, 55404, United States
Children's Hospital Minnesota
Saint Paul, Minnesota, 55102, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Sisters of Charity Hospital
Buffalo, New York, 14214, United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27835, United States
The Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Vanderbilt university Medical Center
Nashville, Tennessee, 37232, United States
North central Baptist Hospital
San Antonio, Texas, 78258, United States
Timpanogos Regional Medical Center
Orem, Utah, 84057, United States
Utah Valley Hospital
Provo, Utah, 84604, United States
University of Virgina Medical Center
Charlottesville, Virginia, 22903, United States
Related Publications (1)
Cummings JJ, Gerday E, Minton S, Katheria A, Albert G, Flores-Torres J, Famuyide M, Lampland A, Guthrie S, Kuehn D, Weitkamp JH, Fort P, Abu Jawdeh EG, Ryan RM, Martin GC, Swanson JR, Mulrooney N, Eyal F, Gerstmann D, Kumar P, Wilding GE, Egan EA; AERO-02 STUDY INVESTIGATORS. Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial. Pediatrics. 2020 Nov;146(5):e20193967. doi: 10.1542/peds.2019-3967. Epub 2020 Oct 15.
PMID: 33060258DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Cummings, MD
- Organization
- Ony Biotech
Study Officials
- STUDY CHAIR
James Cummings, MD
Albany Medical College
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 23, 2017
Study Start
March 29, 2017
Primary Completion
June 1, 2018
Study Completion
July 31, 2018
Last Updated
May 29, 2024
Results First Posted
May 29, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share