InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS

Phase 3

Recruiting

• Conditions: Respiratory Distress Syndrome (Neonatal); Death; Neonatal; Intubation Complication
• Interventions: Combination Product: Infasurf Aero™

• Registration Number: NCT05960929
• Lead Sponsor: ONY

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.

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 Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-07-27
• Status Verified: 2024-11
• Study Start: 2025-01-01
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-01-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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 ≤ 35 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 CPAP
7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
8. If subject is >346/7 weeks' gestation a chest radiograph is required

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. Apgar score < 3 at 5 minutes of age
7. Umbilical cord gas pH <7.0 or BD > 10
8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Infasurf Aero™	Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.
Treatment Arm	Infasurf Aero™	A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer until completion.

Primary Outcome Measures

Name	Time	Method
CPAP failure and or death	Within 1st week of age	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.

Secondary Outcome Measures

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

Trial Locations

Locations (10)

St. Josephs Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Phoenix Children's; 🇺🇸 Phoenix, Arizona, United States

University of Florida -Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Kapi'olani Medical Center for Women & Children; 🇺🇸 Honolulu, Hawaii, United States

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Western TN- Jackson-Madison County General Hospital; 🇺🇸 Jackson, Tennessee, United States

Sharp Mary Birch Hospital for Women & Newborns; 🇺🇸 San Diego, California, United States

Sisters of Charity Hospital; 🇺🇸 Buffalo, New York, United States

Utah Valley Hospital; 🇺🇸 Provo, Utah, United States

Unity Point Meriter; 🇺🇸 Madison, Wisconsin, United States