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

Phase 3

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Drug: Aerosolized Calfactant; Device: Solarys

• Registration Number: NCT03058666
• Lead Sponsor: ONY

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.

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-03-29
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-31
• Results First Submitted: 2023-11-03
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-01
• Last Update Submitted: 2024-05-01
• Results First Posted: 2024-05-29
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerosolized Calfactant	Solarys	1. 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
Aerosolized Calfactant	Aerosolized Calfactant	1. 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

Primary Outcome Measures

Name	Time	Method
Intubation and Instillation of Liquid Surfactant	72 hours	Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

Secondary Outcome Measures

Name	Time	Method
Respiratory Support Requirements	28 days	Difference of Respiratory support at 28 days
Air Leak	28 days	Percent of at risk subjects with air leak at any time

Trial Locations

Locations (22)

Baptist Hospital of Miami; 🇺🇸 Miami, Florida, United States

Sharp Mary Birch Hospital for Women & Newborns; 🇺🇸 San Diego, California, United States

Children's Hospital and Clinics; 🇺🇸 Minneapolis, Minnesota, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

The Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

USA Children's & Women's Hospital; 🇺🇸 Mobile, Alabama, United States

Johns Hopkins All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Adventist Healthcare System, Florida Hospital; 🇺🇸 Orlando, Florida, United States

Sisters of Charity Hospital; 🇺🇸 Buffalo, New York, United States

Columbus Regional Hospital; 🇺🇸 Columbus, Georgia, United States

Jackson-Madison County General Hospital; 🇺🇸 Jackson, Tennessee, United States

Timpanogos Regional Medical Center; 🇺🇸 Orem, Utah, United States

Kentucky Children's Hospital, University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States

Children's Hospital Minnesota; 🇺🇸 Saint Paul, Minnesota, United States

Utah Valley Hospital; 🇺🇸 Provo, Utah, United States

OSF Saint Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

University of South Florida, Tampa general; 🇺🇸 Tampa, Florida, United States

Pitt County Memorial Hospital; 🇺🇸 Greenville, North Carolina, United States

Banner - University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States

Vanderbilt university Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Virgina Medical Center; 🇺🇸 Charlottesville, Virginia, United States

North central Baptist Hospital; 🇺🇸 San Antonio, Texas, United States