Respiratory Distress Syndrome
Conditions
Keywords
Aerosol, surfactant, calfactant, Infasurf, Respiratory Distress Syndrome, RDS, Premature, Neonates
Brief summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Detailed description
Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to usual care and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.
Interventions
DRUGAerosolized Calfactant
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
DEVICESolarys
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Sponsors
ONY
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 24 Hours
Healthy volunteers
No
Inclusion criteria
RDS Patients 1. NICU patient, ≥1hour of age and \<24 hours of age. 2. Clinical diagnosis of RDS, with or without chest X-ray data. 3. Inspired oxygen ≥21% to maintain adequate oxygen saturation. 4. Not intubated 5. Requiring: 1. nasal continuous positive airway pressure (nCPAP).
Exclusion criteria
1. Congenital anomaly limiting care options or requiring early surgery. 2. Cardiopulmonary decompensation. 1. hypotension with metabolic acidosis (base excess \< -10 meq/l). 2. Oxygen saturations \< 88% at start of aerosolization. 3. PaCO2 ≥ 60 mmHg at start of aerosolization. 3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known. 4. Acute hypoxic encephalopathy with or without seizures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation and Instillation of Liquid Surfactant | 72 hours | Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Support Requirements | 28 days | Difference of Respiratory support at 28 days |
| Air Leak | 28 days | Percent of at risk subjects with air leak at any time |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aerosolized Calfactant 1. NICU Patients with a clinical diagnosis of RDS
2. Inspired oxygen ≥21% to maintain adequate oxygen saturation
3. Not Intubated
4. Requiring Nasal continuous positive airway pressure
Aerosolized Calfactant: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Solarys: Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator. | 241 |
| Usual Care There will be no protocol driven interventions in the usual care group. | 236 |
| Total | 477 |
Baseline characteristics
| Characteristic | Usual Care | Total | Aerosolized Calfactant |
|---|---|---|---|
| Age, Categorical <=18 years | 236 Participants | 477 Participants | 241 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 33.1 weeks STANDARD_DEVIATION 3.1 | 33.2 weeks STANDARD_DEVIATION 3.2 | 33.2 weeks STANDARD_DEVIATION 3.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 236 participants | 477 participants | 241 participants |
| Sex: Female, Male Female | 95 Participants | 195 Participants | 100 Participants |
| Sex: Female, Male Male | 141 Participants | 282 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 241 | 1 / 236 |
| other Total, other adverse events | 225 / 241 | 219 / 236 |
| serious Total, serious adverse events | 13 / 241 | 14 / 236 |
Outcome results
Primary
Intubation and Instillation of Liquid Surfactant
Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
Time frame: 72 hours
Population: All enrolled patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aerosolized Calfactant | Intubation and Instillation of Liquid Surfactant | 69 Participants |
| Usual Care | Intubation and Instillation of Liquid Surfactant | 120 Participants |
Secondary
Air Leak
Percent of at risk subjects with air leak at any time
Time frame: 28 days
Population: All Enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aerosolized Calfactant | Air Leak | 14 Participants |
| Usual Care | Air Leak | 11 Participants |
Secondary
Respiratory Support Requirements
Difference of Respiratory support at 28 days
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aerosolized Calfactant | Respiratory Support Requirements | 65 Participants |
| Usual Care | Respiratory Support Requirements | 124 Participants |