Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age
Status:
Terminated
Trial end date:
2021-04-09
Target enrollment:
Participant gender:
Summary
Background. Viral bronchiolitis is a common cause of hospitalization for acute respiratory
insufficiency in young infants. Despite several RCT have tested the effectiveness of various
agents, currently there is no proven specific therapy for bronchiolitis, treatment remaining
mostly supportive. Based on available studies, exogenous surfactant replacement in
bronchiolitis is likely to have a promising safety and efficacy profile. Primary objective.
To evaluate whether Curosurf treatment is effective compared to placebo (air) in reducing the
duration of invasive mechanical ventilation in the first 14 days of hospitalization, in
infants less than 12 months suffering from acute hypoxemic bronchiolitis. Methods. a
multicenter, double-blind, placebo-controlled, randomized trial. 19 Italian PICUs will enroll
children less than12 months with hypoxemic acute bronchiolitis, with need for invasive
mechanical ventilation. Once the patient has been recruited, randomization should occur as
quickly as possible. The first dose of Curosurf or placebo should be administered within 60
minutes of randomization. The treatment may be repeated once, not before 12 hours and not
later than 24 hours after the initial dose. The assignment of the type of treatment will be
communicated by the Coordinator center to the researcher attending the patient's bed. The
same medical researcher will then take care of administering the assigned treatment, masking
the procedure with appropriate precautions, for example with screens or closing the patient's
room whenever possible. The preparation and administration of treatment, medication or
placebo, can be done by a nurse who must not disclose the assigned treatment and will not be
involved in the patient's care until the conclusion of the study. Patient evaluation will be
carried out by other physicians and/or nurses who will not be aware of the assigned
treatment. Regardless the received treatment, all patients will be assisted according to
standard practice of the Unit. For the purposes of the study, several parameters will be
collected 15 minutes before, and 2, 6, 12, 24, 36, 48 hours after administration of the drug:
oxygenation indexes such as OI, OSI, PaO2 and SatO2; Invasive ventilation parameters, i.e.
current volume, positive end expiratory pressure, peak pressure, respiratory rate, FiO2 and
mean airway pressure; and ventilation indexes such as PaCO2 and End Tidal CO2. If it is
necessary to repeat the treatment, the above parameters will be re-collected with the same
timepoints. During the study all the AE/ADR will be recorded.