Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058666
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
ONY

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Aerosolized Calfactant Device: Solarys Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Calfactant

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Intubation [ Time Frame: 72 hours ]
    Incidence of the requirement for endotracheal intubation and instillation of surfactant to "usual care".


Secondary Outcome Measures :
  1. Death [ Time Frame: 28 days ]
    Incidence of death

  2. Bronchopulmonary Dysplasia [ Time Frame: 28 days or discharge ]
    Incidence of Bronchopulmonary Dysplasia defined as oxygen requirement to maintain acceptable blood oxygenation saturations.

  3. Severity of Acute RDS [ Time Frame: Randomization to 72 hours of age or to intubation ]
    Measured by oxygen requirements and respiratory support


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058666


Locations
Show Show 22 study locations
Sponsors and Collaborators
ONY
Investigators
Layout table for investigator information
Study Chair: James Cummings, MD Albany Medical College
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: ONY
ClinicalTrials.gov Identifier: NCT03058666    
Other Study ID Numbers: Aero-02
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by ONY:
Aerosol
surfactant
calfactant
Infasurf
 Respiratory Distress Syndrome
RDS
Premature
Neonates
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
 Infant, Premature, Diseases
Infant, Newborn, Diseases
Calfactant
Pulmonary Surfactants
Respiratory System Agents