Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
![]() |
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03582930 |
Expanded Access Status :
Available
First Posted : July 11, 2018
Last Update Posted : October 31, 2022
|
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
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.

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.
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 | Info@onybiotech.com |
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 |
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 |
Infasurf Surfactant RDS Respiratory Distress Syndrome Aerosolized |
Nebulized Inhaled Pre-term Premature |
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 |