Clinical trial
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Name
Aero-02
Description
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Trial arms
Trial start
2017-03-29
Estimated PCD
2018-06-01
Trial end
2018-07-31
Status
Completed
Phase
Early phase I
Treatment
Aerosolized Calfactant
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Arms:
Aerosolized Calfactant
Other names:
Infasurf, Calfactant
Solarys
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Arms:
Aerosolized Calfactant
Size
477
Primary endpoint
Intubation and Instillation of Liquid Surfactant
72 hours
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 477, 'type': 'ACTUAL'}}
Updated at
2024-05-29
1 organization
1 product
1 indication
Organization
ONYProduct
CalfactantIndication
Respiratory Distress Syndrome