Trial Outcomes & Findings for Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients (NCT NCT03058666)

NCT ID: NCT03058666

Last Updated: 2024-05-29

Results Overview

Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

477 participants

Primary outcome timeframe

72 hours

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Usual Care There will be no protocol driven interventions in the usual care group.
Overall Study STARTED	241	236
Overall Study COMPLETED	241	236
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerosolized Calfactant n=241 Participants 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.	Usual Care n=236 Participants There will be no protocol driven interventions in the usual care group.	Total n=477 Participants Total of all reporting groups
Age, Categorical <=18 years	241 Participants n=241 Participants	236 Participants n=236 Participants	477 Participants n=477 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=241 Participants	0 Participants n=236 Participants	0 Participants n=477 Participants
Age, Categorical >=65 years	0 Participants n=241 Participants	0 Participants n=236 Participants	0 Participants n=477 Participants
Age, Continuous	33.2 weeks STANDARD_DEVIATION 3.2 • n=241 Participants	33.1 weeks STANDARD_DEVIATION 3.1 • n=236 Participants	33.2 weeks STANDARD_DEVIATION 3.2 • n=477 Participants
Sex: Female, Male Female	100 Participants n=241 Participants	95 Participants n=236 Participants	195 Participants n=477 Participants
Sex: Female, Male Male	141 Participants n=241 Participants	141 Participants n=236 Participants	282 Participants n=477 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	241 participants n=241 Participants	236 participants n=236 Participants	477 participants n=477 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: All enrolled patients.

Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

Outcome measures

Outcome measures
Measure	Aerosolized Calfactant n=241 Participants 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.	Usual Care n=236 Participants There will be no protocol driven interventions in the usual care group.
Intubation and Instillation of Liquid Surfactant	69 Participants	120 Participants

SECONDARY outcome

Timeframe: 28 days

Difference of Respiratory support at 28 days

Outcome measures

Outcome measures
Measure	Aerosolized Calfactant n=241 Participants 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.	Usual Care n=236 Participants There will be no protocol driven interventions in the usual care group.
Respiratory Support Requirements	65 Participants	124 Participants

SECONDARY outcome

Timeframe: 28 days

Population: All Enrolled

Percent of at risk subjects with air leak at any time

Outcome measures

Outcome measures
Measure	Aerosolized Calfactant n=241 Participants 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.	Usual Care n=236 Participants There will be no protocol driven interventions in the usual care group.
Air Leak	14 Participants	11 Participants

Adverse Events

Aerosolized Calfactant

Serious events: 13 serious events

Other events: 225 other events

Deaths: 0 deaths

Usual Care

Serious events: 14 serious events

Other events: 219 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

James Cummings, MD

Ony Biotech

Phone: 7166369096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Aerosolized Calfactant n=241 participants at risk 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.	Usual Care n=236 participants at risk There will be no protocol driven interventions in the usual care group.
Respiratory, thoracic and mediastinal disorders Air Leak	5.4% 13/241 • Number of events 23 • Birth to 28 days or discharge, whichever came first.	5.9% 14/236 • Number of events 23 • Birth to 28 days or discharge, whichever came first.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/241 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Blood and lymphatic system disorders Thrombocytopenia	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Blood and lymphatic system disorders Neutropenia	0.00% 0/241 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Cardiac disorders Patent ductus arteriosus	2.5% 6/241 • Number of events 6 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Endocrine disorders Adrenal insufficiency	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Eye disorders Conjunctivitis	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Abdominal distension	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Spontaneous intestinal perforation	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Necrotizing enterocolitis	1.2% 3/241 • Number of events 3 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Infections and infestations Meningitis	0.00% 0/241 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Infections and infestations Sepsis	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	1.7% 4/236 • Number of events 4 • Birth to 28 days or discharge, whichever came first.
Nervous system disorders Intraventricular hemorrhage, Grade IV	0.00% 0/241 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Nervous system disorders Periventricular leukomalacia	0.00% 0/241 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Primary pulmonary hypertension	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Injury, poisoning and procedural complications Pink colored oral discharge secretion	0.83% 2/241 • Number of events 2 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Pulmonary Hemorrhage	0.41% 1/241 • Number of events 1 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.

Measure	Aerosolized Calfactant n=241 participants at risk 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.	Usual Care n=236 participants at risk There will be no protocol driven interventions in the usual care group.
Blood and lymphatic system disorders Anemia	22.0% 53/241 • Number of events 53 • Birth to 28 days or discharge, whichever came first.	22.9% 54/236 • Number of events 54 • Birth to 28 days or discharge, whichever came first.
Blood and lymphatic system disorders Neutropenia	3.3% 8/241 • Number of events 8 • Birth to 28 days or discharge, whichever came first.	1.7% 4/236 • Number of events 4 • Birth to 28 days or discharge, whichever came first.
Blood and lymphatic system disorders Polycythemia	1.7% 4/241 • Number of events 4 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Blood and lymphatic system disorders Thrombocytopenia	6.6% 16/241 • Number of events 16 • Birth to 28 days or discharge, whichever came first.	5.1% 12/236 • Number of events 12 • Birth to 28 days or discharge, whichever came first.
Cardiac disorders Bradycardia	2.9% 7/241 • Number of events 7 • Birth to 28 days or discharge, whichever came first.	2.5% 6/236 • Number of events 6 • Birth to 28 days or discharge, whichever came first.
Cardiac disorders Hypotension	2.1% 5/241 • Number of events 5 • Birth to 28 days or discharge, whichever came first.	1.7% 4/236 • Number of events 4 • Birth to 28 days or discharge, whichever came first.
Cardiac disorders Patent ductus arteriosus	10.4% 25/241 • Number of events 25 • Birth to 28 days or discharge, whichever came first.	11.4% 27/236 • Number of events 27 • Birth to 28 days or discharge, whichever came first.
Hepatobiliary disorders Hyperbilirubinemia	80.9% 195/241 • Number of events 195 • Birth to 28 days or discharge, whichever came first.	80.9% 191/236 • Number of events 191 • Birth to 28 days or discharge, whichever came first.
Endocrine disorders Hypocalcemia	4.6% 11/241 • Number of events 11 • Birth to 28 days or discharge, whichever came first.	5.5% 13/236 • Number of events 13 • Birth to 28 days or discharge, whichever came first.
Endocrine disorders Hypophosphatemia	2.1% 5/241 • Number of events 5 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Eye disorders Conjunctivitis	1.7% 4/241 • Number of events 4 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Eye disorders Retinopathy of prematurity	1.2% 3/241 • Number of events 3 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Abdominal distension	2.5% 6/241 • Number of events 6 • Birth to 28 days or discharge, whichever came first.	3.4% 8/236 • Number of events 8 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Dysphagia	19.5% 47/241 • Number of events 47 • Birth to 28 days or discharge, whichever came first.	15.7% 37/236 • Number of events 37 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Emesis	3.3% 8/241 • Number of events 8 • Birth to 28 days or discharge, whichever came first.	3.8% 9/236 • Number of events 9 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Feeding Intolerance	3.7% 9/241 • Number of events 9 • Birth to 28 days or discharge, whichever came first.	3.8% 9/236 • Number of events 9 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Gastroesophageal reflux	5.4% 13/241 • Number of events 13 • Birth to 28 days or discharge, whichever came first.	3.8% 9/236 • Number of events 9 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Necrotizing enterocolitis neonatal	2.1% 5/241 • Number of events 5 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Gastrointestinal disorders Unspecified nutritional deficiency	1.2% 3/241 • Number of events 3 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Infections and infestations Infection	5.0% 12/241 • Number of events 12 • Birth to 28 days or discharge, whichever came first.	3.0% 7/236 • Number of events 7 • Birth to 28 days or discharge, whichever came first.
Infections and infestations Sepsis	5.8% 14/241 • Number of events 14 • Birth to 28 days or discharge, whichever came first.	14.0% 33/236 • Number of events 33 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Alkaline phosphatase increase	1.2% 3/241 • Number of events 3 • Birth to 28 days or discharge, whichever came first.	1.7% 4/236 • Number of events 4 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hyperglycemia	1.2% 3/241 • Number of events 3 • Birth to 28 days or discharge, whichever came first.	2.1% 5/236 • Number of events 5 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hyperkalemia	1.7% 4/241 • Number of events 4 • Birth to 28 days or discharge, whichever came first.	1.7% 4/236 • Number of events 4 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hypomagnesemia	5.0% 12/241 • Number of events 12 • Birth to 28 days or discharge, whichever came first.	3.0% 7/236 • Number of events 7 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hypernatremia	8.3% 20/241 • Number of events 20 • Birth to 28 days or discharge, whichever came first.	6.8% 16/236 • Number of events 16 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hypochloremia	1.2% 3/241 • Number of events 3 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hypoglycemia	12.9% 31/241 • Number of events 31 • Birth to 28 days or discharge, whichever came first.	16.1% 38/236 • Number of events 38 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hypokalemia	2.1% 5/241 • Number of events 5 • Birth to 28 days or discharge, whichever came first.	0.00% 0/236 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Hyponatremia	10.8% 26/241 • Number of events 26 • Birth to 28 days or discharge, whichever came first.	10.2% 24/236 • Number of events 24 • Birth to 28 days or discharge, whichever came first.
Metabolism and nutrition disorders Metabolic acidosis	6.6% 16/241 • Number of events 16 • Birth to 28 days or discharge, whichever came first.	5.5% 13/236 • Number of events 13 • Birth to 28 days or discharge, whichever came first.
Nervous system disorders Apnea	48.1% 116/241 • Number of events 116 • Birth to 28 days or discharge, whichever came first.	45.8% 108/236 • Number of events 108 • Birth to 28 days or discharge, whichever came first.
Nervous system disorders Intraventricular hemorrhage grade I	2.1% 5/241 • Number of events 5 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Nervous system disorders Intraventricular hemorrhage grade II	4.1% 10/241 • Number of events 10 • Birth to 28 days or discharge, whichever came first.	1.3% 3/236 • Number of events 3 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary dysplasia	8.7% 21/241 • Number of events 21 • Birth to 28 days or discharge, whichever came first.	7.2% 17/236 • Number of events 17 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Hypoxemia	2.5% 6/241 • Number of events 6 • Birth to 28 days or discharge, whichever came first.	4.7% 11/236 • Number of events 11 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	1.7% 4/241 • Number of events 4 • Birth to 28 days or discharge, whichever came first.	0.42% 1/236 • Number of events 1 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 5/241 • Number of events 5 • Birth to 28 days or discharge, whichever came first.	0.85% 2/236 • Number of events 2 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Pulmonary interstitial emphysema	1.2% 3/241 • Number of events 3 • Birth to 28 days or discharge, whichever came first.	1.3% 3/236 • Number of events 3 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Respiratory insufficiency	10.0% 24/241 • Number of events 24 • Birth to 28 days or discharge, whichever came first.	5.9% 14/236 • Number of events 14 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Tachypnea	1.7% 4/241 • Number of events 4 • Birth to 28 days or discharge, whichever came first.	3.4% 8/236 • Number of events 8 • Birth to 28 days or discharge, whichever came first.
Respiratory, thoracic and mediastinal disorders Diaper Rash	1.7% 4/241 • Number of events 4 • Birth to 28 days or discharge, whichever came first.	1.7% 4/236 • Number of events 4 • Birth to 28 days or discharge, whichever came first.
Vascular disorders Hypovolemia	3.3% 8/241 • Number of events 8 • Birth to 28 days or discharge, whichever came first.	3.8% 9/236 • Number of events 9 • Birth to 28 days or discharge, whichever came first.