A Phase 3 interventional study of Curosurf 80Mg/Ml Intratracheal Suspension and Ambient Air in Bronchiolitis, Viral, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Terminated at 1 site in Italy. Open to participants aged 40 Weeks to 12 Months. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Phase 3, Interventional, and Treatment
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.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 9 is below the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Broncho-alveolar lavage (BAL) with 25 mg / kg of Curosurf, diluted 1:10 with physiological solution, divided in two aliquots administered with a endotracheal tube in two different postures (1st BAL on right decubitus, 2nd BAL on left decubitus). 2. Following supplementation of a dose of 25 mg / kg of Curosurf, diluted with physiological solution 1: 2 (1 ml = 40 mg of surfactant), given in two aliquots with endotracheal tube in two different postures (1st on right decubitus, 2nd on left decubitus). The treatment assigned may be repeated at least 12 hours later and in any case within 24 hours from the first treatment, at the same dosage and with the same method of administration
Drug: Curosurf 80Mg/Ml Intratracheal Suspension
1. Broncho-alveolar lavage (BAL) with air, administered with a endotracheal tube in two different postures (1st BAL on right decubitus, 2nd BAL on left decubitus). 2. Following supplementation of air given with endotracheal tube in two different postures (1st on right decubitus, 2nd on left decubitus). The treatment assigned may be repeated at least 12 hours later and in any case within 24 hours from the first treatment, at the same dosage and with the same method of administration
Other: Ambient Air
Drug page: Poractant alfa
CUROSURF is a natural surfactant obtained from swine lungs containing almost exclusively phospholipids, in particular phosphatidylcholine (about 70% of the total phospholipid content) and about 1% of low molecular weight hydrophobic proteins, specific for surfactant, SP-B and SP -C. CUROSURF will be administered via endotracheopulmunary.
Also known as: phospholipid fraction from porcine lung
Ambient air aspirated in sterile syringes
Number of days free from invasive mechanical ventilation
Number of days free from invasive mechanical ventilation within the first 14 days of hospitalization. Ventilation-free days will start after the first successful extubation (at least 48 hours without the need for re-intubation)
Time frame: day 14
Number of days free from non-invasive mechanical ventilation in the post-extubation phase
Number of days free from non-invasive mechanical ventilation in the post-extubation phase
Time frame: day 14
Number of cases requiring new intubation
Number of cases requiring new intubation after previous extubation in 14 days from randomization.
Time frame: day 14
Number of days of patients in PICU
Number of days of patients in PICU
Time frame: day 14
Number of days of hospitalization
Number of days of hospitalization.
Time frame: day 14
Number of days free from oxygen supplementation
Number of days free from oxygen supplementation
Time frame: day 14
Values of the Oxygen Saturation Index (OSI)
Changes in the Oxygen Saturation Index (OSI)
Time frame: detected 15 minutes before administration of treatment and at a distance of 2, 6, 12, 24, 36 and 48 hours
Values of the mechanical ventilation parameter (MAP) during invasive mechanical respiratory support
Changes in the ventilatory parameter (MAP) during invasive mechanical respiratory support
Time frame: detected 15 minutes before administration of treatment and at a distance of 2, 6, 12, 24, 36 and 48 hours
Number of patients undergoing a repeated treatment (Curosurf or placebo)
Number of patients undergoing a repeated treatment (Curosurf or placebo). The repetition of the assigned treatment may take place at least 12 hours apart and in any case within 24 hours of the first treatment, at the same dosage and with the same method of administration
Time frame: within 24 hours of the first treatment
Number of patients undergoing unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO)
Number of patients undergoing unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO)
Time frame: during the first 14 days
Rate of deaths
Rate of deaths before hospital discharge
Time frame: (1) Mortality during the first 14 days of hospitalization (2) Mortality from the date of the first intervention until the date of hospital discharge
Number of serious desaturation episodes, severe bradycardia, extreme bradycardia or cardiac arrest, pulmonary hemorrhage, pneumothorax
Number of serious desaturation episodes (SatO2 \< 75%), episodes of severe bradycardia (FC \< 80/min) , episodes of extreme bradycardia or cardiac arrest with the need for chest compressions and/or administration of drugs for resuscitation, episodes of pulmonary hemorrhage, episodes of pneumothorax
Time frame: within the first 48 hours after treatment
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data will be available within 9 months of study completion, up to five years
Access criteria: Data access request will be reviewed by the Steering committee. Requestors wil be required to sign a Data Access Agreement
This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Poractant alfa
Azienda Ospedaliera Universitaria Integrata Verona