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Trial record 48 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

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 : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
ONY

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

Detailed 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.

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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)



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.

Information from the National Library of Medicine

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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

  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.

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
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Contact: Corey Commaroto, RRT 7164283124 ext 124 ccommaroto@onybiotech.com
Contact: Dan Swartz, PhD dswartz@onybiotech.com

Sponsors and Collaborators
ONY
Investigators
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Study Chair: Jim Cummings, MD Albany Medical College

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Responsible Party: ONY
ClinicalTrials.gov Identifier: NCT03582930     History of Changes
Other Study ID Numbers: Aero-03
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Keywords provided by ONY:
Infasurf
Surfactant
RDS
Respiratory Distress Syndrome
Aerosolized
Nebulized
Inhaled
Pre-term
Premature
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Calfactant
Pulmonary Surfactants
Respiratory System Agents