Trial record 1 of 1 for:
Aero-03
Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
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| ClinicalTrials.gov Identifier: NCT03582930 |
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Expanded Access Status :
Available
First Posted : July 11, 2018
Last Update Posted : October 31, 2022
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Sponsor:
ONY
Information provided by (Responsible Party):
ONY
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Brief Summary:
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS). Currently, such therapy requires instillation of a liquid suspension into the trachea through an endotracheal tube. Endotracheal intubations have undesirable adverse effects on fragile premature infants. Instilling surfactant as a liquid suspension into the lung is associated with adverse events due to interruption of breathing in patients who already have respiratory insufficiency. This treatment protocol is expanded access that offers the opportunity for patients to receive aerosolized Infasurf prior to FDA acting on ONY Biotech's application for approval for commercial marketing of aerosolized Infasurf.
| Condition or disease | Intervention/treatment |
|---|---|
| Neonatal Respiratory Distress | Combination Product: Infasurf Aero |
This Treatment Protocol will offer patients access to aerosolized Infasurf therapy at the time RDS is diagnosed if a patient is <12 hours of age and has not previously received liquid surfactant, or is <24 hours of age, and received liquid surfactant in the first hour after birth, was extubated and RDS is worsening. Parents must give informed consent. Up to 2 repeat doses of aerosolized Infasurf can be administered. Aerosolized Infasurf must be administered as described in the protocol. Adverse events at administration (if any) and all serious adverse events related or possibly related the aerosolized Infasurf therapy will be extracted from the medical record and reported to the sponsor, ONY Biotech. A copy of the discharge summary of patients will be collected by the sponsor using HIPAA compliant methodology for generation of a data set that will characterize adverse events and other efficacy and safety data.
| Study Type : | Expanded Access |
| Expanded Access Type : | Treatment IND/Protocol |
| Official Title: | Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03) |
Resource links provided by the National Library of Medicine
Drug Information available for:
Calfactant
Intervention Details:
- Combination Product: Infasurf Aero
Aerosolization of Infasurf administered to premature babies suffering from RDS. Successful administration of Infasurf by aerosolization will provide two important benefits for patients. (1) endotracheal intubation may be able to be avoided in some patients, and (2) the adverse events at instillation due to filling the airway with liquid and interrupting breathing may be diminished or abolished.
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| Ages Eligible for Study: | up to 42 Weeks (Child) |
| Sexes Eligible for Study: | All |
Criteria
Inclusion Criteria:
Two cohorts with different entry criteria are included. In cohort 1 are patients with a diagnosis of early RDS who are not intubated and have not received a liquid surfactant instillation. In cohort 2 are patients who received liquid surfactant in the first hour of life, have been extubated and whose RDS is worsening.
Cohort 1 Inclusion Criteria
- NICU patient, <12 hours of age.
- Clinical diagnosis of RDS, with or without chest X-ray data.
- Inspired oxygen ≤40% to maintain adequate oxygen saturation.
- Not intubated
- Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.
Cohort 2 Inclusion Criteria
- NICU patient, <24 hours of age who received liquid surfactant at ≤ 1 hour of age and was extubated.
- Clinical diagnosis of RDS, with or without chest X-ray data.
- Inspired oxygen ≤40% to maintain adequate oxygen saturation.
- Not intubated
- Requiring: (a) nasal continuous positive airway pressure (nCPAP), or (b) high flow nasal cannula (≥2L/kg/min) (HFNC), or (c) non-invasive ventilation.
Exclusion Criteria:
- 1) Requires >40% inspired oxygen to maintain acceptable oxygenation 2) Requires endotracheal intubation. 3) A co-existing medical condition that makes aerosol administration contraindicated in the judgment of the attending physician.
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): NCT03582930
Contacts
| Contact: Corey Commaroto, RRT | 7164283124 ext 124 | ccommaroto@onybiotech.com | |
| Contact: Dan Swartz, PhD | Info@onybiotech.com |
Locations
| United States, Mississippi | |
| University of Mississippi Medical Center | Available |
| Jackson, Mississippi, United States, 39216 | |
| Contact: Heather Williams, RN, Study Coordinator 601-815-3070 hbarth@umc.edu | |
| Principal Investigator: Mobolaji Famuyide, MD | |
| United States, New York | |
| Sisters of Charity Hospital | Available |
| Buffalo, New York, United States, 14214 | |
| Contact: George Albert, MD 716-862-1000 | |
| Principal Investigator: George Albert, MD | |
| United States, North Carolina | |
| Pitt County Memorial Hospital | Available |
| Greenville, North Carolina, United States, 27835 | |
| Contact: Sherry Moseley, RN moseleysh@ecu.edu | |
| Principal Investigator: Srikanth Ravisankar, MD | |
| United States, Tennessee | |
| Jackson-Madison County General Hospital | Available |
| Jackson, Tennessee, United States, 38301 | |
| Contact: Sharon Wadley, BSN sharon.wadley@wth.org | |
| Principal Investigator: Scott Guthrie, MD | |
| United States, Utah | |
| Utah Valley Hospital | Available |
| Provo, Utah, United States, 84604 | |
| Contact: Tonya Edvalson, BS,CCRP 801-507-7036 tonya.edvalson@imail.org | |
| Principal Investigator: Steven Minton, MD | |
Sponsors and Collaborators
ONY
Investigators
| Study Chair: | Jim Cummings, MD | Albany Medical College |
| Responsible Party: | ONY |
| ClinicalTrials.gov Identifier: | NCT03582930 |
| Other Study ID Numbers: |
Aero-03 |
| First Posted: | July 11, 2018 Key Record Dates |
| Last Update Posted: | October 31, 2022 |
| Last Verified: | October 2022 |
Keywords provided by ONY:
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Infasurf Surfactant RDS Respiratory Distress Syndrome Aerosolized |
Nebulized Inhaled Pre-term Premature |
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome Lung Diseases Respiratory Tract Diseases Respiration Disorders |
Infant, Premature, Diseases Infant, Newborn, Diseases Calfactant Pulmonary Surfactants Respiratory System Agents |