Clinical trial NCT03058666: Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Official title: Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome
Keywords: Aerosol
surfactant
calfactant
Infasurf
Respiratory Distress Syndrome
RDS
Premature
Neonates
Lead sponsor: ONY
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 477
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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:

   1. nasal continuous positive airway pressure (nCPAP).

Exclusion Criteria:

1. Congenital anomaly limiting care options or requiring early surgery.
2. Cardiopulmonary decompensation.

   1. hypotension with metabolic acidosis (base excess \< -10 meq/l).
   2. Oxygen saturations \< 88% at start of aerosolization.
   3. PaCO2 ≥ 60 mmHg at start of aerosolization.
3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
4. Acute hypoxic encephalopathy with or without seizures.

Primary outcomes:
measure: Intubation and Instillation of Liquid Surfactant
timeFrame: 72 hours
Secondary outcomes:
measure: Respiratory Support Requirements
timeFrame: 28 days
measure: Air Leak
timeFrame: 28 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Children's & Women's Hospital
state: Alabama
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women & Newborns
state: California
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Adventist Healthcare System, Florida Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Tampa general
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Hospital
state: Georgia
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Lexington
country: United States
facility: Kentucky Children's Hospital, University of Kentucky Medical Center
state: Kentucky
city: Minneapolis
country: United States
facility: Children's Hospital and Clinics
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Hospital Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Buffalo
country: United States
facility: Sisters of Charity Hospital
state: New York
city: Greenville
country: United States
facility: Pitt County Memorial Hospital
state: North Carolina
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt university Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: North central Baptist Hospital
state: Texas
city: Orem
country: United States
facility: Timpanogos Regional Medical Center
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Charlottesville
country: United States
facility: University of Virgina Medical Center
state: Virginia
Study officials:
affiliation: Albany Medical College
name: James Cummings, MD
role: STUDY_CHAIR
References:
citation: 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.