Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
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ClinicalTrials.gov Identifier: NCT03582930 |
Expanded Access Status :
Available
First Posted : July 11, 2018
Last Update Posted : October 23, 2020
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Condition or disease | Intervention/treatment |
---|---|
Neonatal Respiratory Distress | Combination Product: Infasurf Aero |
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) |

- 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 |
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.

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
Contact: Corey Commaroto, RRT | 7164283124 ext 124 | ccommaroto@onybiotech.com | |
Contact: Dan Swartz, PhD | dswartz@onybiotech.com |
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 23, 2020 |
Last Verified: | October 2020 |
Infasurf Surfactant RDS Respiratory Distress Syndrome Aerosolized |
Nebulized Inhaled Pre-term Premature |
Respiratory Distress Syndrome, Newborn Respiration Disorders Respiratory Tract Diseases Lung Diseases Infant, Premature, Diseases |
Infant, Newborn, Diseases Calfactant Pulmonary Surfactants Respiratory System Agents |