InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (Aero-05)

InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

Study Overview

• Status: Not yet recruiting
• Conditions: Intubation Complication; Death; Neonatal; Respiratory Distress Syndrome (Neonatal)
• Intervention / Treatment: Combination product: Infasurf Aero™

Detailed Description

This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.

The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.

Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Corey Commaroto, RRT; Phone Number: 7163614659; Email: ccommaroto@onybiotech.com
• Study Contact Backup: Name: Dan Swartz, PhD; Phone Number: 716428-3132; Email: dswartz@onybiotech.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women & Newborns
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
      • Contact: Study Coordinator
      • Principal Investigator: Prem Fort, MD
  • New York
    • Buffalo, New York, United States, 14214
      • Sisters of Charity Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
      • Principal Investigator: Scott Guthrie, MD
      • Contact: Sharon Wadley, BSN
  • Utah
    • Provo, Utah, United States, 84604
      • Utah Valley Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Unity Point Meriter
      • Contact: Study Coordinator
      • Principal Investigator: Dinushuan Kaluarachchi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion criteria include ALL of the following:

1. Written informed consent obtained by parent or legal representative prior to or after birth
2. Gestational age at birth ≥ 29 0/7 AND ≤ 36 6/7 weeks
3. Birthweight ≥ 1,000 AND ≤ 3,500 grams
4. Age ≥ 1 hour AND ≤ 6 hours
5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
6. Require non-invasive respiratory support (i.e., continuous positive airway pressure or non-invasive ventilation)
7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4

Exclusion Criteria:

Exclusion criteria are ANY of the following:

1. Surfactant administration prior to randomization
2. Mechanical ventilation prior to randomization
3. Major congenital anomaly (suspected or confirmed)
4. Abnormality of the airway (suspected or confirmed)
5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
6. Culture-positive bacterial sepsis requiring at least 5 days of antibiotic therapy
7. Apgar score < 3 at 5 minutes of age
8. Umbilical cord gas pH <7.0 or BD > 10
9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.	Combination product: Infasurf Aero™; A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Sham Comparator: Control Arm; Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.	Combination product: Infasurf Aero™; A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPAP failure and or death	CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) >2.5 on two consecutive assessments at least 30 minutes apart, or an RSS > 2.4 and one or more of the following: (i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support. (ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation). (iii) Respiratory acidosis (pCO2 > 65 with a pH < 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.	Within 1st week of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic lung disease and or death	Chronic lung disease is defined as altitude adjusted oxygen requirement at 36 weeks post menstrual age.	36 weeks post menstrual age (PMA).
Incidence of MV	Incidence of Mechanical Ventilation	36 weeks PMA
Duration of MV	length of time of Mechanical Ventilation	36 weeks PMA
Incidence of intubation	Any occurrence of tracheal intubation	36 weeks PMA
Incidence of invasive surfactant replacement therapy	any occurrence of liquid surfactant administration via and endotracheal tube	72 hours post birth
Duration of non-invasive support	Length of time of respiratory support other than Intubation	36 weeks PMA
Duration of supplemental oxygen	Length of time any oxygen is administered.	36 weeks PMA

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events during surfactant administration.	Incidence of bradycardia and desaturation during surfactant administration.	Birth to 72 hours of age.

Collaborators and Investigators

• Sponsor: ONY
• Collaborators: Avania
• Investigators: Study Chair: Scott Guthrie, MD, Vanderbilt Jackson-Madison, Jackson TN; Study Chair: Dinushan Kaluarachchi, MD, Unity Point Meriter, Madison WI; Study Director: Jim Cummings, MD, Ony Biotech

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: CPAP; Inhalation; Intubation; NICU; Nebulization; Neonatal; Aerosol; Preterm; Respiratory Distress Syndrome; Infasurf; Calfactant; InfasurfAero; CPAP Failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Pulmonary Surfactants; Calfactant
• Other Study ID Numbers: AERO-05 Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes