Death; Neonatal, Intubation Complication, Respiratory Distress Syndrome (Neonatal)
Conditions
Keywords
Infasurf, Calfactant, Inhalation, Nebulization, Preterm, InfasurfAero, Respiratory Distress Syndrome, Neonatal, NICU, CPAP, Intubation, Aerosol, CPAP Failure
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.
Interventions
COMBINATION_PRODUCTInfasurf Aero™
A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.
Sponsors
Avania
ONY
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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™.
Eligibility
Sex/Gender
ALL
Age
29 Weeks to 36 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| Incidence of intubation | 36 weeks PMA | Any occurrence of tracheal intubation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events during surfactant administration. | Birth to 72 hours of age. | Incidence of bradycardia and desaturation during surfactant administration. |
Countries
United States
Contacts
Primary ContactCorey Commaroto, RRT
Backup ContactDan Swartz, PhD
Outcome results
None listed