Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
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| ClinicalTrials.gov Identifier: NCT03058666 |
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Recruitment Status :
Completed
First Posted : February 23, 2017
Last Update Posted : March 13, 2019
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Sponsor:
ONY
Information provided by (Responsible Party):
ONY
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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 |
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 (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
| Arm | Intervention/treatment |
|---|---|
Experimental: Aerosolized Calfactant
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Drug: Aerosolized Calfactant
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Other Names:
Device: Solarys Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. |
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No Intervention: Usual Care
There will be no protocol driven interventions in the usual care group.
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Primary Outcome Measures :
- Intubation [ Time Frame: 72 hours ]Incidence of the requirement for endotracheal intubation and instillation of surfactant to "usual care".
Secondary Outcome Measures :
- Death [ Time Frame: 28 days ]Incidence of death
- Bronchopulmonary Dysplasia [ Time Frame: 28 days or discharge ]Incidence of Bronchopulmonary Dysplasia defined as oxygen requirement to maintain acceptable blood oxygenation saturations.
- Severity of Acute RDS [ Time Frame: Randomization to 72 hours of age or to intubation ]Measured by oxygen requirements and respiratory support
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| Ages Eligible for Study: | up to 24 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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Requiring:
- nasal continuous positive airway pressure (nCPAP).
Exclusion Criteria:
- Congenital anomaly limiting care options or requiring early surgery.
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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.
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 22 study locations
Sponsors and Collaborators
ONY
Investigators
| Study Chair: | James Cummings, MD | Albany Medical College |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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:
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Aerosol surfactant calfactant Infasurf |
Respiratory Distress Syndrome RDS Premature Neonates |
Additional relevant MeSH terms:
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Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Lung Diseases Respiratory Tract Diseases Respiration Disorders |
Infant, Premature, Diseases Infant, Newborn, Diseases Calfactant Pulmonary Surfactants Respiratory System Agents |