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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Aerosolized Calfactant; Device: Solarys

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 Type: Interventional
• Enrollment (Actual): 477
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • USA Children's & Women's Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner - University Medical Center Phoenix
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women & Newborns
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Orlando, Florida, United States, 32803
      • Adventist Healthcare System, Florida Hospital
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
    • Tampa, Florida, United States, 33606
      • University of South Florida, Tampa general
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Hospital
  • Illinois
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Kentucky Children's Hospital, University of Kentucky Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospital and Clinics
    • Saint Paul, Minnesota, United States, 55102
      • Children's Hospital Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New York
    • Buffalo, New York, United States, 14214
      • Sisters of Charity Hospital
  • North Carolina
    • Greenville, North Carolina, United States, 27835
      • Pitt County Memorial Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • The Medical University of South Carolina
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78258
      • North Central Baptist Hospital
  • Utah
    • Orem, Utah, United States, 84057
      • Timpanogos Regional Medical Center
    • Provo, Utah, United States, 84604
      • Utah Valley Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virgina Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerosolized Calfactant; NICU Patients with a clinical diagnosis of RDS; Inspired oxygen ≥21% to maintain adequate oxygen saturation; Not Intubated; Requiring Nasal continuous positive airway pressure	Drug: Aerosolized Calfactant; Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.; Other Names: Infasurf; Calfactant; Device: Solarys; Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
No Intervention: Usual Care; There will be no protocol driven interventions in the usual care group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation	Incidence of the requirement for endotracheal intubation and instillation of surfactant to "usual care".	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Incidence of death	28 days
Bronchopulmonary Dysplasia	Incidence of Bronchopulmonary Dysplasia defined as oxygen requirement to maintain acceptable blood oxygenation saturations.	28 days or discharge
Severity of Acute RDS	Measured by oxygen requirements and respiratory support	Randomization to 72 hours of age or to intubation

Collaborators and Investigators

• Sponsor: ONY
• Investigators: Study Chair: James Cummings, MD, Albany Medical College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: RDS; Neonates; Premature; Aerosol; surfactant; Respiratory Distress Syndrome; Infasurf; calfactant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants; Calfactant
• Other Study ID Numbers: Aero-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes