Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

NCT03582930 | Unknown

• 1 other identifier: Aero-03
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Neonatal Respiratory Distress

Keywords

Infasurf; Surfactant; RDS; Respiratory Distress Syndrome; Aerosolized; Nebulized; Inhaled; Pre-term; Premature

Interventions

Infasurf Aero COMBINATION_PRODUCT

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.

Eligibility Criteria

• Age: Up to 42 Weeks
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• ONY: lead

Study Sites (5)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

Location

Pitt County Memorial Hospital

Greenville, North Carolina, 27835, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome; Respiratory Aspiration; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jim Cummings, MD

  Albany Medical College

  STUDY CHAIR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 11, 2018
• Last Updated: November 7, 2023

Record last verified: 2022-10

Locations

US (5)