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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT03582930
Other study ID # Aero-03
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date October 2022
Source ONY
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A to 42 Weeks
Eligibility 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 1. NICU patient, <12 hours of age. 2. Clinical diagnosis of RDS, with or without chest X-ray data. 3. Inspired oxygen =40% to maintain adequate oxygen saturation. 4. Not intubated 5. 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 1. NICU patient, <24 hours of age who received liquid surfactant at = 1 hour of age and was extubated. 2. Clinical diagnosis of RDS, with or without chest X-ray data. 3. Inspired oxygen =40% to maintain adequate oxygen saturation. 4. Not intubated 5. 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Sisters of Charity Hospital Buffalo New York
United States Pitt County Memorial Hospital Greenville North Carolina
United States Jackson-Madison County General Hospital Jackson Tennessee
United States University of Mississippi Medical Center Jackson Mississippi
United States Utah Valley Hospital Provo Utah

Sponsors (1)

Lead Sponsor Collaborator
ONY

Country where clinical trial is conducted

United States, 

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