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

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058666
• Other study ID #: Aero-02
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: May 2024
• Source: ONY
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: July 31, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 24 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Aerosolized Calfactant
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

Device:
• Solarys
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ONY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory Support Requirements	Difference of Respiratory support at 28 days	28 days
Secondary	Air Leak	Percent of at risk subjects with air leak at any time	28 days