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

Sponsor

ONY (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05960929

Collaborator

Avania (Industry)

220

Enrollment

Locations

Arms

Anticipated Duration (Months)

36.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome (Neonatal) Intubation Complication Death; Neonatal	Combination Product: Infasurf Aero™	Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model 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™.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™.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
Duration of MV [36 weeks PMA]
length of time 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.

Other Outcome Measures

Adverse events during surfactant administration. [Birth to 72 hours of age.]
Incidence of bradycardia and desaturation during surfactant administration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

29 Weeks to 36 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion criteria include ALL of the following:

Written informed consent obtained by parent or legal representative prior to or after birth
Gestational age at birth ≥ 29 0/7 AND ≤ 36 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 non-invasive respiratory support (i.e., continuous positive airway pressure or non-invasive ventilation)
Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4

Exclusion Criteria:

Exclusion criteria are ANY of the following:

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)
Culture-positive bacterial sepsis requiring at least 5 days of antibiotic therapy
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California	United States	92123
2	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida	United States	33701
3	Sisters of Charity Hospital	Buffalo	New York	United States	14214
4	Jackson-Madison County General Hospital	Jackson	Tennessee	United States	38301
5	Utah Valley Hospital	Provo	Utah	United States	84604
6	Unity Point Meriter	Madison	Wisconsin	United States	53715