Trial | NCT03058666  Report issue

Official Title

Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

  • Phase

    Phase 3

  • Lead Sponsor

    ONY

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    calfactant ...

  • Study Participants

    477
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
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.
Study Started
Mar 29
2017
Primary Completion
Jun 01
2018
Study Completion
Jul 31
2018
Last Update
Mar 13
2019

Drug Aerosolized Calfactant

Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

  • Other names: Infasurf, Calfactant

Device Solarys

Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

Aerosolized Calfactant Experimental

NICU Patients with a clinical diagnosis of RDS Inspired oxygen ≥21% to maintain adequate oxygen saturation Not Intubated Requiring Nasal continuous positive airway pressure

Usual Care No Intervention

There will be no protocol driven interventions in the usual care group.

Criteria 

Inclusion Criteria:

RDS Patients

NICU patient, ≥1hour of age and <24 hours of age.
Clinical diagnosis of RDS, with or without chest X-ray data.
Inspired oxygen ≥21% to maintain adequate oxygen saturation.
Not intubated

Requiring:

nasal continuous positive airway pressure (nCPAP).

Exclusion Criteria:

Congenital anomaly limiting care options or requiring early surgery.

Cardiopulmonary decompensation.

hypotension with metabolic acidosis (base excess < -10 meq/l).
Oxygen saturations < 88% at start of aerosolization.
PaCO2 ≥ 60 mmHg at start of aerosolization.
Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
Acute hypoxic encephalopathy with or without seizures.
No Results Posted