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

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aerosolized Calfactant
Solarys
Sponsored by
ONY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring Aerosol, surfactant, calfactant, Infasurf, Respiratory Distress Syndrome, RDS, Premature, Neonates

Eligibility Criteria

1 Hour - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USA Children's & Women's Hospital
  • Banner - University Medical Center Phoenix
  • Sharp Mary Birch Hospital for Women & Newborns
  • Baptist Hospital of Miami
  • Adventist Healthcare System, Florida Hospital
  • Johns Hopkins All Children's Hospital
  • University of South Florida, Tampa general
  • Columbus Regional Hospital
  • OSF Saint Francis Medical Center
  • Kentucky Children's Hospital, University of Kentucky Medical Center
  • Children's Hospital and Clinics
  • Children's Hospital Minnesota
  • University of Mississippi Medical Center
  • Sisters of Charity Hospital
  • Pitt County Memorial Hospital
  • The Medical University of South Carolina
  • Jackson-Madison County General Hospital
  • Vanderbilt university Medical Center
  • North central Baptist Hospital
  • Timpanogos Regional Medical Center
  • Utah Valley Hospital
  • University of Virgina Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerosolized Calfactant

Usual Care

Arm Description

NICU Patients with a clinical diagnosis of RDS Inspired oxygen ≥21% to maintain adequate oxygen saturation Not Intubated Requiring Nasal continuous positive airway pressure

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

Outcomes

Primary Outcome Measures

Intubation
Incidence of the requirement for endotracheal intubation and instillation of surfactant to "usual care".

Secondary Outcome Measures

Death
Incidence of death
Bronchopulmonary Dysplasia
Incidence of Bronchopulmonary Dysplasia defined as oxygen requirement to maintain acceptable blood oxygenation saturations.
Severity of Acute RDS
Measured by oxygen requirements and respiratory support

Full Information

First Posted
February 16, 2017
Last Updated
March 11, 2019
Sponsor
ONY
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1. Study Identification

Unique Protocol Identification Number
NCT03058666
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ONY

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Aerosol, surfactant, calfactant, Infasurf, Respiratory Distress Syndrome, RDS, Premature, Neonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerosolized Calfactant
Arm Type
Experimental
Arm Description
NICU Patients with a clinical diagnosis of RDS Inspired oxygen ≥21% to maintain adequate oxygen saturation Not Intubated Requiring Nasal continuous positive airway pressure
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
There will be no protocol driven interventions in the usual care group.
Intervention Type
Drug
Intervention Name(s)
Aerosolized Calfactant
Other Intervention Name(s)
Infasurf, Calfactant
Intervention Description
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Intervention Type
Device
Intervention Name(s)
Solarys
Intervention Description
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Primary Outcome Measure Information:
Title
Intubation
Description
Incidence of the requirement for endotracheal intubation and instillation of surfactant to "usual care".
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Death
Description
Incidence of death
Time Frame
28 days
Title
Bronchopulmonary Dysplasia
Description
Incidence of Bronchopulmonary Dysplasia defined as oxygen requirement to maintain acceptable blood oxygenation saturations.
Time Frame
28 days or discharge
Title
Severity of Acute RDS
Description
Measured by oxygen requirements and respiratory support
Time Frame
Randomization to 72 hours of age or to intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Cummings, MD
Organizational Affiliation
Albany Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
USA Children's & Women's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Banner - University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Sharp Mary Birch Hospital for Women & Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Adventist Healthcare System, Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
University of South Florida, Tampa general
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Columbus Regional Hospital
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Kentucky Children's Hospital, University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Children's Hospital and Clinics
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Children's Hospital Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Sisters of Charity Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
Pitt County Memorial Hospital
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835
Country
United States
Facility Name
The Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Jackson-Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Vanderbilt university Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
North central Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Timpanogos Regional Medical Center
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
Facility Name
Utah Valley Hospital
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
University of Virgina Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33060258
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.
Results Reference
derived

Learn more about this trial

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

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