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

NCT ID: NCT03058666

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 477 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2018-07-31

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Aerosolized Calfactant

Intervention Type: DRUG

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

Solarys

Intervention Type: DEVICE

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

Usual Care

There will be no protocol driven interventions in the usual care group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aerosolized Calfactant

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

Intervention Type: DRUG

Solarys

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

Intervention Type: DEVICE

Other Intervention Names

Infasurf; Calfactant

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.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ONY

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Cummings, MD

Role: STUDY_CHAIR

Albany Medical College

Locations

USA Children's & Women's Hospital

Mobile, Alabama, United States

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

Baptist Hospital of Miami

Miami, Florida, United States

Adventist Healthcare System, Florida Hospital

Orlando, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

University of South Florida, Tampa general

Tampa, Florida, United States

Columbus Regional Hospital

Columbus, Georgia, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Kentucky Children's Hospital, University of Kentucky Medical Center

Lexington, Kentucky, United States

Children's Hospital and Clinics

Minneapolis, Minnesota, United States

Children's Hospital Minnesota

Saint Paul, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Sisters of Charity Hospital

Buffalo, New York, United States

Pitt County Memorial Hospital

Greenville, North Carolina, United States

The Medical University of South Carolina

Charleston, South Carolina, United States

Jackson-Madison County General Hospital

Jackson, Tennessee, United States

Vanderbilt university Medical Center

Nashville, Tennessee, United States

North central Baptist Hospital

San Antonio, Texas, United States

Timpanogos Regional Medical Center

Orem, Utah, United States

Utah Valley Hospital

Provo, Utah, United States

University of Virgina Medical Center

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33060258 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Aero-02

Identifier Type: -

Identifier Source: org_study_id