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出境医 / 临床实验 / Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age

Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis, Viral Drug: Curosurf 80Mg/Ml Intratracheal Suspension Other: Ambient Air Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter, double-blind, placebo-controlled, randomized trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patient's parents and the doctors/nurses responsible for the patient's care will be blinded. At each center only a physician and a nurse will know and prepare the drug or placebo, being subsequently not clinically involved in the care of that particular patient. The assignment of the type of treatment will be communicated by the Coordinator centre in an individual way and reserved to the researcher attending the patient's bed. The same medical researcher will then take care of administering the treatment assigned to the patient, masking the procedure with appropriate precautions. The preparation and administration of treatment can be done with the help of a nurse who does not have to disclose the type of treatment assigned. Thereafter, such a nurse will not be involved in the patient's care until the conclusion of the study. The patient evaluation will be carried out by other physicians and/or nurses who will not be aware of the type of treatment carried out.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Curosurf® in Patients Under 12 Months of Age Requiring Invasive Mechanical Ventilation for Acute Respiratory Distress Syndrome in the Course of Bronchiolitis: A Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : January 9, 2019
Actual Primary Completion Date : April 9, 2021
Actual Study Completion Date : April 9, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Surfactant replacement (Curosurf)
  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
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.
Other Name: phospholipid fraction from porcine lung
Placebo Comparator: Ambient Air
  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
Ambient air aspirated in sterile syringes
Outcome Measures
Primary Outcome Measures :
  1. Number of days free from invasive mechanical ventilation [ Time Frame: day 14 ]
    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)


Secondary Outcome Measures :
  1. Number of days free from non-invasive mechanical ventilation in the post-extubation phase [ Time Frame: day 14 ]
    Number of days free from non-invasive mechanical ventilation in the post-extubation phase

  2. Number of cases requiring new intubation [ Time Frame: day 14 ]
    Number of cases requiring new intubation after previous extubation in 14 days from randomization.

  3. Number of days of patients in PICU [ Time Frame: day 14 ]
    Number of days of patients in PICU

  4. Number of days of hospitalization [ Time Frame: day 14 ]
    Number of days of hospitalization.

  5. Number of days free from oxygen supplementation [ Time Frame: day 14 ]
    Number of days free from oxygen supplementation

  6. Values of 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 ]
    Changes in the Oxygen Saturation Index (OSI)

  7. Values of the mechanical ventilation 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 ]
    Changes in the ventilatory parameter (MAP) during invasive mechanical respiratory support

  8. Number of patients undergoing a repeated treatment (Curosurf or placebo) [ Time Frame: within 24 hours of the first treatment ]
    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

  9. Number of patients undergoing unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO) [ Time Frame: during the first 14 days ]
    Number of patients undergoing unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO)

  10. Rate of deaths [ 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 ]
    Rate of deaths before hospital discharge

  11. Number of serious desaturation episodes, severe bradycardia, extreme bradycardia or cardiac arrest, pulmonary hemorrhage, pneumothorax [ Time Frame: within the first 48 hours after treatment ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Weeks to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged > 40 weeks (correct gestational age) and < 12 months.
  2. Patient intubated and mechanically ventilated for at least 6 hours, with expected requirement of ventilatory support of at least 24 hours.
  3. Clinical picture strongly suggestive for acute bronchiolitis (fever of probable viral origin, fine crackles, prolonged expiration, lung hyperexpansion on chest X-ray)
  4. Moderate or severe pediatric acute respiratory distress syndrome, defined by a Oxygenation Index (OI) > 8 or an Oxygen Saturation Index (OSI) > 7.5
  5. Written informed consent obtained from both parents

Exclusion Criteria:

  1. Severe prematurity (gestational age < 32 weeks). Patients with gestational age less than 32 weeks will be excluded because they are considered at high risk for respiratory pathology following their severe prematurity. This consideration does not apply in successive gestational ages. Therefore patients with mild prematurity, i.e. with gestational age equal to or greater than 32 weeks, are not to be excluded.
  2. Recent phase of oxygen dependency (need for oxygen supplementation to maintain satO2 > 94% in the four weeks preceding hospitalization in Pediatric ICU)
  3. Invasive mechanical ventilation for more than 24 hours.
  4. Oxygenation index (OI) > 30
  5. Cyanotic congenital heart disease
  6. Untreated pneumothorax
  7. Neuromuscular diseases
  8. Severe Neurological Alterations
  9. Other severe congenital anomalies
  10. Indication not to attempt resuscitation
  11. Patient already recruited for other clinical studies
Contacts and Locations

Locations
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Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
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Principal Investigator: Paolo Biban, MD AOUI Verona
Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE January 9, 2019
Actual Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Number of days free from invasive mechanical ventilation [ Time Frame: day 14 ]
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)
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019) 		Curosurf efficacy in reducing duration of invasive mechanical ventilation in the first 14 days of hospitalization: duration of invasive mechanical ventilation [ Time Frame: day 14 ]
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 children suffering from acute hypoxemic bronchiolitis of viral origin, under the age of 12 months, admitted in the pediatric intensive care Unit (PICU)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Number of days free from non-invasive mechanical ventilation in the post-extubation phase [ Time Frame: day 14 ]
    Number of days free from non-invasive mechanical ventilation in the post-extubation phase
  • Number of cases requiring new intubation [ Time Frame: day 14 ]
    Number of cases requiring new intubation after previous extubation in 14 days from randomization.
  • Number of days of patients in PICU [ Time Frame: day 14 ]
    Number of days of patients in PICU
  • Number of days of hospitalization [ Time Frame: day 14 ]
    Number of days of hospitalization.
  • Number of days free from oxygen supplementation [ Time Frame: day 14 ]
    Number of days free from oxygen supplementation
  • Values of 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 ]
    Changes in the Oxygen Saturation Index (OSI)
  • Values of the mechanical ventilation 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 ]
    Changes in the ventilatory parameter (MAP) during invasive mechanical respiratory support
  • Number of patients undergoing a repeated treatment (Curosurf or placebo) [ Time Frame: within 24 hours of the first treatment ]
    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
  • Number of patients undergoing unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO) [ Time Frame: during the first 14 days ]
    Number of patients undergoing unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO)
  • Rate of deaths [ 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 ]
    Rate of deaths before hospital discharge
  • Number of serious desaturation episodes, severe bradycardia, extreme bradycardia or cardiac arrest, pulmonary hemorrhage, pneumothorax [ Time Frame: within the first 48 hours after treatment ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Curosurf efficacy in reducing duration of non-invasive mechanical ventilation in the post-extubation phase: duration of non-invasive mechanical ventilation [ Time Frame: day 14 ]
    A. Evaluate whether Curosurf treatment is effective compared to placebo in reducing the duration of non-invasive mechanical ventilation in the post-extubation phase.
  • Curosurf efficacy in reducing the number of cases requiring new intubation after previous extubation in 14 days from randomization: number of cases requiring new intubation [ Time Frame: day 14 ]
    B. Evaluate whether Curosurf treatment is effective compared to placebo in reducing the number of cases requiring new intubation after previous extubation in 14 days from randomization.
  • Curosurf efficacy in reducing the days of patients in PICU: days of patients in PICU [ Time Frame: day 14 ]
    C. Assessing the efficacy of Curosurf compared to placebo in reducing the days of patients in PICU
  • Curosurf efficacy in reducing the days of hospitalization: days of hospitalization [ Time Frame: day 14 ]
    D. Assessing the efficacy of Curosurf in reducing the days of hospitalization.
  • Curosurf efficacy in reducing the duration of oxygen dependency: duration of oxygen dependency [ Time Frame: day 14 ]
    E. Assessing the efficacy of Curosurf in reducing the duration of oxygen dependency
  • Changes in oxygenation and ventilation index (OSI) [ Time Frame: detected 15 minutes before administration of treatment and at a distance of 2, 6, 12, 24, 36 and 48 hours ]
    F. Evaluate the efficacy of Curosurf in improving oxygenation and ventilation (OSI) of patients treated with respect to placebo.
  • Changes in values of the mechanical ventilation 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 ]
    G. Assessing the efficacy of Curosurf in improving ventilatory parameter (MAP) during invasive mechanical respiratory support
  • Curosurf efficacy in reducing the number of patients undergoing a repeated treatment within 24 hours of first treatment [ Time Frame: within 24 hours of the first treatment ]
    H. Assessing the efficacy of Curosurf in reducing the need for repeating treatment within 24 hours of first treatment
  • Curosurf efficacy in reducing the number of patients undergoing unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO) [ Time Frame: during the first 14 days ]
    I. Assessing the efficacy of Curosurf in reducing the use of other unconventional or more invasive treatments (HFOV, Nitric Oxide, ECMO)
  • Curosurf efficacy in terms of rate of deaths within the first 14 days of hospitalization in intensive care and anyway 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 ]
    J. Assessing the efficacy of Curosorf in terms of mortality within the first 14 days of hospitalization in pediatric intensive care and anyway before hospital discharge.
  • Number of serious desaturation episodes, severe bradycardia, extreme bradycardia or cardiac arrest, pulmonary hemorrhage, pneumothorax [ Time Frame: within the first 48 hours after treatment ]
    K. Assessing the safety and tolerability of Curosurf monitoring the 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age
Official Title  ICMJE Efficacy and Safety of Curosurf® in Patients Under 12 Months of Age Requiring Invasive Mechanical Ventilation for Acute Respiratory Distress Syndrome in the Course of Bronchiolitis: A Randomized, Double-blind, Placebo-controlled Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
multicenter, double-blind, placebo-controlled, randomized trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Patient's parents and the doctors/nurses responsible for the patient's care will be blinded. At each center only a physician and a nurse will know and prepare the drug or placebo, being subsequently not clinically involved in the care of that particular patient. The assignment of the type of treatment will be communicated by the Coordinator centre in an individual way and reserved to the researcher attending the patient's bed. The same medical researcher will then take care of administering the treatment assigned to the patient, masking the procedure with appropriate precautions. The preparation and administration of treatment can be done with the help of a nurse who does not have to disclose the type of treatment assigned. Thereafter, such a nurse will not be involved in the patient's care until the conclusion of the study. The patient evaluation will be carried out by other physicians and/or nurses who will not be aware of the type of treatment carried out.
Primary Purpose: Treatment
Condition  ICMJE Bronchiolitis, Viral
Intervention  ICMJE
  • Drug: Curosurf 80Mg/Ml Intratracheal Suspension
    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.
    Other Name: phospholipid fraction from porcine lung
  • Other: Ambient Air
    Ambient air aspirated in sterile syringes
Study Arms  ICMJE
  • Experimental: Surfactant replacement (Curosurf)
    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
    Intervention: Drug: Curosurf 80Mg/Ml Intratracheal Suspension
  • Placebo Comparator: Ambient Air
    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
    Intervention: Other: Ambient Air
Publications * Biban P, Conti G, Wolfler AM, Carlassara S, Gitto E, Rulli I, Moscatelli A, Micalizzi C, Savron F, Sagredini R, Genoni G, Binotti M, Caramelli F, Fae M, Pettenazzo A, Stritoni V, D'Amato L, Zito Marinosci G, Calderini E, Scalia Catenacci S, Berardi A, Torcetta F, Bonanomi E, Bonacina D, Ivani G, Santuz P. Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial. BMJ Open. 2020 Oct 19;10(10):e038780. doi: 10.1136/bmjopen-2020-038780.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 12, 2021) 		9
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		172
Actual Study Completion Date  ICMJE April 9, 2021
Actual Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged > 40 weeks (correct gestational age) and < 12 months.
  2. Patient intubated and mechanically ventilated for at least 6 hours, with expected requirement of ventilatory support of at least 24 hours.
  3. Clinical picture strongly suggestive for acute bronchiolitis (fever of probable viral origin, fine crackles, prolonged expiration, lung hyperexpansion on chest X-ray)
  4. Moderate or severe pediatric acute respiratory distress syndrome, defined by a Oxygenation Index (OI) > 8 or an Oxygen Saturation Index (OSI) > 7.5
  5. Written informed consent obtained from both parents

Exclusion Criteria:

  1. Severe prematurity (gestational age < 32 weeks). Patients with gestational age less than 32 weeks will be excluded because they are considered at high risk for respiratory pathology following their severe prematurity. This consideration does not apply in successive gestational ages. Therefore patients with mild prematurity, i.e. with gestational age equal to or greater than 32 weeks, are not to be excluded.
  2. Recent phase of oxygen dependency (need for oxygen supplementation to maintain satO2 > 94% in the four weeks preceding hospitalization in Pediatric ICU)
  3. Invasive mechanical ventilation for more than 24 hours.
  4. Oxygenation index (OI) > 30
  5. Cyanotic congenital heart disease
  6. Untreated pneumothorax
  7. Neuromuscular diseases
  8. Severe Neurological Alterations
  9. Other severe congenital anomalies
  10. Indication not to attempt resuscitation
  11. Patient already recruited for other clinical studies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Weeks to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959384
Other Study ID Numbers  ICMJE SURFABRON
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
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
Responsible Party Paolo Biban, Azienda Ospedaliera Universitaria Integrata Verona
Study Sponsor  ICMJE Azienda Ospedaliera Universitaria Integrata Verona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paolo Biban, MD AOUI Verona
PRS Account Azienda Ospedaliera Universitaria Integrata Verona
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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