InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

NCT05960929 | Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: AERO-05 Protocol
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Respiratory Distress Syndrome (Neonatal); Intubation Complication; Death; Neonatal

Keywords

Infasurf; Calfactant; Inhalation; Nebulization; Preterm; InfasurfAero; Respiratory Distress Syndrome; Neonatal; NICU; CPAP; Intubation; Aerosol; CPAP Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Chronic lung disease and or death

  36 weeks post menstrual age (PMA).

• Incidence of MV

  36 weeks PMA

• Duration of MV

  36 weeks PMA

• Incidence of intubation

  36 weeks PMA

• Incidence of invasive surfactant replacement therapy

  72 hours post birth

Other Outcomes (1)

• Adverse events during surfactant administration.

  Birth to 72 hours of age.

Study Arms (2)

Treatment Arm

EXPERIMENTAL

A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.

Combination Product: Infasurf Aero™

Control Arm

SHAM COMPARATOR

Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.

Combination Product: Infasurf Aero™

Interventions

Infasurf Aero™ COMBINATION_PRODUCT

A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 29 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent obtained by parent or legal representative prior to or after birth
• Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
• Birthweight ≥ 1,000 AND ≤ 3,500 grams
• Age ≥ 1 hour AND ≤ 6 hours
• 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
• Require CPAP
• Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
• If subject is \>346/7 weeks' gestation a chest radiograph is required

You may not qualify if:

• Surfactant administration prior to randomization
• Mechanical ventilation prior to randomization
• Major congenital anomaly (suspected or confirmed)
• Abnormality of the airway (suspected or confirmed)
• 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)
• Apgar score \< 3 at 5 minutes of age
• Umbilical cord gas pH \<7.0 or BD \> 10
• Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Sponsors & Collaborators

• ONY: lead
• Avania: collaborator

Study Sites (10)

St. Josephs Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

Phoenix Children's

Phoenix, Arizona, 85016, United States

RECRUITING

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

RECRUITING

University of Florida -Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

RECRUITING

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

RECRUITING

Western TN- Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

RECRUITING

Utah Valley Hospital

Provo, Utah, 84604, United States

RECRUITING

Unity Point Meriter

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Scott Guthrie, MD

  Vanderbilt Jackson-Madison, Jackson TN

  STUDY CHAIR

• Dinushan Kaluarachchi, MD

  Unity Point Meriter, Madison WI

  STUDY CHAIR

• Jim Cummings, MD

  Ony Biotech

  STUDY DIRECTOR

Central Study Contacts

Corey Commaroto, RRT

CONTACT

7163614659; ccommaroto@onybiotech.com

Dan Swartz, PhD

CONTACT

716428-3132; dswartz@onybiotech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study procedures will be performed behind a portable screen or curtain, or in a separate procedure room so that non-study personnel (including the primary care team) will be unaware of the subject's assigned study arm. Study personnel involved in the study procedure will not be masked. All other study personnel including the investigator and the outcomes accessor will be masked throughout the duration of the study. The subject's family will remain blinded to treatment assignment throughout.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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™.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 27, 2023
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)