InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

Intubation Complication Clinical Trial

— Aero-05  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960929
• Other study ID #: AERO-05 Protocol
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: ONY
• Contact: Corey Commaroto, RRT
• Phone: 7163614659
• Email: ccommaroto[@]onybiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Death; Neonatal
• Intubation Complication
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
United States	Sisters of Charity Hospital	Buffalo	New York
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Unity Point Meriter	Madison	Wisconsin
United States	Utah Valley Hospital	Provo	Utah
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
ONY	Avania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events during surfactant administration.	Incidence of bradycardia and desaturation during surfactant administration.	Birth to 72 hours of age.
Primary	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	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).
Secondary	Incidence of MV	Incidence of Mechanical Ventilation	36 weeks PMA
Secondary	Duration of MV	length of time of Mechanical Ventilation	36 weeks PMA
Secondary	Incidence of intubation	Any occurrence of tracheal intubation	36 weeks PMA
Secondary	Incidence of invasive surfactant replacement therapy	any occurrence of liquid surfactant administration via and endotracheal tube	72 hours post birth
Secondary	Duration of non-invasive support	Length of time of respiratory support other than Intubation	36 weeks PMA
Secondary	Duration of supplemental oxygen	Length of time any oxygen is administered.	36 weeks PMA