<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02977585</url>
  </required_header>
  <id_info>
    <org_study_id>1239_OPBG_2016</org_study_id>
    <nct_id>NCT02977585</nct_id>
  </id_info>
  <brief_title>Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs</brief_title>
  <official_title>Helmet Continous Positive Airway Pressure (CPAP) Management and Positive End Expiratory Pressure (PEEP) Level Impact on Severe Bronchiolitis Admitted in Pediatric Intensive Care Units (PICUs)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bambino Gesù Hospital and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bambino Gesù Hospital and Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign&#xD;
      to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients&#xD;
      enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25&#xD;
      patients at least.&#xD;
&#xD;
        -  10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU&#xD;
           admission (random 1)&#xD;
&#xD;
        -  5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and&#xD;
           respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2&#xD;
           occurs in the following first hour after Helmet CPAP treatment start, patients enrolled&#xD;
           will receive endotracheal intubation, full face mask non invasive ventilation or higher&#xD;
           peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.&#xD;
&#xD;
      In investigator's experience, early worsening of severe bronchiolitis in PICU in the first&#xD;
      hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      Newborns and infants with severe bronchiolitis admitted in PICU (Pediatric Intensive Care&#xD;
      Unit) are patients at high risk for invasive mechanical ventilation support. In current&#xD;
      literature, there is lack of multicenter, prospective and randomized studies to assess and&#xD;
      describe the impact of non invasive ventilation support among severe bronchiolitis admitted&#xD;
      in PICU, notwithstanding the actual improvement of non invasive ventilation technique on&#xD;
      intubation rate reduction.&#xD;
&#xD;
      Recently, we can find studies on bronchiolitis management in pediatric ward and supported&#xD;
      with high flow nasal cannula (HFNC).&#xD;
&#xD;
      The studies on severe bronchiolitis admitted in PICU do not evaluate positive end expiratory&#xD;
      pressure (Peep) level applied during Helmet continous positive airway pressure (CPAP)&#xD;
      support.&#xD;
&#xD;
      According to Italian PICU Network (TIPNET) data, severe bronchiolitis admitted in PICU&#xD;
      intubation rate is close to 10% (report 2010-2016), whatever non invasive ventilation support&#xD;
      has been used.&#xD;
&#xD;
      Principal investigators have performed a retrospective and cohort chart review among severe&#xD;
      bronchiolitis (82) admitted in PICU from 2011 to 2015. Early Helmet CPAP was applied to&#xD;
      patients, but peep level has been provided according to clinician experience, because of lack&#xD;
      of indication on this issue. Patients were admitted in PICU from Emergency department,&#xD;
      pediatric ward and up to 72 hours of ineffective HFNC support. The investigators have studied&#xD;
      intubation rate, length of stay, bronchiolitis severity score, virus infection, peep level&#xD;
      and gas flow applied on Helmet CPAP.&#xD;
&#xD;
      According to preliminary results, 10 cmH2O peep level results 50 time more protective than&#xD;
      lower (5-7.5 cmH2O) peep among flow rate of 50 L/min.&#xD;
&#xD;
      Intubation rate with peep level 10 cmH2O was 3%, while it rose over 15% among 7.5-5 cmH2O&#xD;
      peep level. Statistically significant difference were found on length of PICU stay.&#xD;
&#xD;
      Scientific literature on Helmet CPAP noising exposure is poor. Such noising was proved to be&#xD;
      reduced with filter application on Helmet CPAP respiratory circuit. There are not report, and&#xD;
      we have never experienced acoustic system impairment in patients undergone Helmet CPAP.&#xD;
&#xD;
      AIMS Primary aim: to evaluate escalation therapy (higher peep, non invasive ventilation in&#xD;
      pressure support mode, or intubation and mechanical ventilation) rate on severe bronchiolitis&#xD;
      admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 cmH2O peep&#xD;
      level in group 1, and 5 cmH2O peep level in group 0.&#xD;
&#xD;
      Secondary aim: to evaluate, among two study groups, length of PICU stay, pneumothorax&#xD;
      incidence on Helmet CPAP, sedation effect during Helmet CPAP, early enteral feeding&#xD;
      tolerance, syncytial and other respiratory virus incidence, bacterial infection and 30 days&#xD;
      outcome.&#xD;
&#xD;
      DESIGN Prospective, randomized, cohort, controlled and multicentric study.&#xD;
&#xD;
      Population: sample size The study requires 488 patients, enrolled among 20 national and&#xD;
      international PICU. Sample size have been calculated on preliminary results of our&#xD;
      retrospective chart review; we hypothesize that intubation rate with 5 cmH2O peep level is&#xD;
      15% and application of 10 cmH2O peep level may reduce it to 50%. According to these&#xD;
      hypothesis, we need 244 patients for each group to have 5% of significativity level and 80%&#xD;
      of study power.&#xD;
&#xD;
      Length of study 24 months&#xD;
&#xD;
      Procedure and methods&#xD;
&#xD;
      Selection and patient enrollment Severe bronchiolitis admitted in PICU and requiring&#xD;
      respiratory support.&#xD;
&#xD;
      Intervention&#xD;
&#xD;
      Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign&#xD;
      to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients&#xD;
      enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25&#xD;
      patients at least.&#xD;
&#xD;
        -  10 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 1)&#xD;
&#xD;
        -  5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and&#xD;
           respiratory worsening, reduction of pH or PaO2/FiO2 occurs in the following first hour&#xD;
           after Helmet CPAP treatment start, patients enrolled will receive endotracheal&#xD;
           intubation, full face mask non invasive ventilation or higher peep level treatment&#xD;
           (7.5-10 cmH2O) according to clinical evaluation, if necessary.&#xD;
&#xD;
      In investigators' experience, early worsening of severe bronchiolitis in PICU in the first&#xD;
      hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.&#xD;
&#xD;
      STUDY PLAN Application of a standard treatment protocol for all patients enrolled. It is the&#xD;
      same standard of care applied to treat these patients in our PICU in the last 2 years. Of&#xD;
      course, patients who will not be enrolled in the study will be supported and treated with the&#xD;
      best feasible care.&#xD;
&#xD;
        -  Registration of the modified Wood's Clinical Asthma score (mWCAS) for severe&#xD;
           bronchiolitis admitted in PICU (Bronchiolitis Severity Score-BSS)&#xD;
&#xD;
        -  clarithromycin prophylaxis for newborns (up to 30 days old), or I generation&#xD;
           cephalosporine for older infants, if high fever, lung opacities or high inflammation&#xD;
           markers occurs (PCR, procalcitonin, White body cells)&#xD;
&#xD;
        -  volume replacement (20 ml/kg of sodium chloride solution or albumine 5%) in 60 min&#xD;
&#xD;
        -  morphine ev bolus: 20 mcg/kg in 2 min and following 5 mcg/kg/h infusion (or other&#xD;
           sedatives according to local PICU investigator)&#xD;
&#xD;
        -  nasogastric tube placement and early enteral feeding 4-6 hours after admission (5-10&#xD;
           ml/h)&#xD;
&#xD;
        -  desamethasone 0.2 mg/kg x3/die ev (according to local PICU investigator ).&#xD;
&#xD;
        -  proton pump inhibitors or H2 receptor antagonist (according to local PICU investigator).&#xD;
&#xD;
        -  aerosol therapy 4 time/die: sodium chloride hypertonic solution 3% (or sodium chloride&#xD;
           0.9%) 2 ml with ipratropium bromide .&#xD;
&#xD;
        -  Arterial blood gas exam (ABE) before Helmet CPAP application and in the following 1,12&#xD;
           24, and 48 hours; arterial catheter positioning is preferred (or arterial blood sampling&#xD;
           by direct arterial puncture according to local PICU practice).&#xD;
&#xD;
        -  Pharyngeal swab for molecular analysis to detect viral DNA will be performed on PICU&#xD;
           admission, if not yet performed.&#xD;
&#xD;
        -  occipital and neck skin protection will be used to avoid Helmet CPAP pressure sores.&#xD;
&#xD;
        -  each Helmet will be provided of a filter to reduce noise inside it.&#xD;
&#xD;
        -  Helmet gas will flow through heat-moisture device switched on 5 min/hour&#xD;
&#xD;
      Only patients whose parents have signed written informed consent will be enrolled in this&#xD;
      study. Any direct follow up is supposed after PICU discharge. Monitoring of hospital&#xD;
      discharge will be followed by intranet database of the participant hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID 19 PANDEMIA&#xD;
  </why_stopped>
  <start_date type="Actual">November 2, 2016</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of intubation following Helmet CPAP treatment</measure>
    <time_frame>7 days</time_frame>
    <description>to evaluate intubation rate on severe bronchiolitis admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 peep level in group 1, and 5 peep level in group 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of pneumothorax following Helmet CPAP treatment</measure>
    <time_frame>72 hours</time_frame>
    <description>pneumothorax occurrence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of stay</measure>
    <time_frame>days 30</time_frame>
    <description>length of PICU stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Critically Ill Severe Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>high level support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 0</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>low level support</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>10 cmH2O peep</intervention_name>
    <description>positive end expiratory pressure</description>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of 38 weeks of gestational age up to 18 months old, admitted in PICU for&#xD;
             severe bronchiolitis, whose parents have signed written informed consent to enroll the&#xD;
             child in the study.&#xD;
&#xD;
          -  Patients with severe bronchiolitis moved from emergency department, pediatric ward,&#xD;
             and supported up to 72 hours with HFNC or O2 therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe congenital malformation Inborn congenital error Neonatal or postnatal&#xD;
             neurologic disorder Parents refusal to study participation Presence or supposed&#xD;
             pneumothorax on chest X-ray or lung ultrasound&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>38 Weeks</minimum_age>
    <maximum_age>18 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bambino Gesù Children's Hospital</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Donlan M, Fontela PS, Puligandla PS. Use of continuous positive airway pressure (CPAP) in acute viral bronchiolitis: a systematic review. Pediatr Pulmonol. 2011 Aug;46(8):736-46. doi: 10.1002/ppul.21483. Epub 2011 May 26.</citation>
    <PMID>21618716</PMID>
  </reference>
  <reference>
    <citation>Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.</citation>
    <PMID>24612137</PMID>
  </reference>
  <reference>
    <citation>Trevisanuto D, Camiletti L, Doglioni N, Cavallin F, Udilano A, Zanardo V. Noise exposure is increased with neonatal helmet CPAP in comparison with conventional nasal CPAP. Acta Anaesthesiol Scand. 2011 Jan;55(1):35-8. doi: 10.1111/j.1399-6576.2010.02356.x. Epub 2010 Nov 15.</citation>
    <PMID>21077846</PMID>
  </reference>
  <reference>
    <citation>Chidini G, Piastra M, Marchesi T, De Luca D, Napolitano L, Salvo I, Wolfler A, Pelosi P, Damasco M, Conti G, Calderini E. Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT. Pediatrics. 2015 Apr;135(4):e868-75. doi: 10.1542/peds.2014-1142. Epub 2015 Mar 16.</citation>
    <PMID>25780074</PMID>
  </reference>
  <reference>
    <citation>Ganu SS, Gautam A, Wilkins B, Egan J. Increase in use of non-invasive ventilation for infants with severe bronchiolitis is associated with decline in intubation rates over a decade. Intensive Care Med. 2012 Jul;38(7):1177-83. doi: 10.1007/s00134-012-2566-4. Epub 2012 Apr 18.</citation>
    <PMID>22527081</PMID>
  </reference>
  <reference>
    <citation>Milani GP, Plebani AM, Arturi E, Brusa D, Esposito S, Dell'Era L, Laicini EA, Consonni D, Agostoni C, Fossali EF. Using a high-flow nasal cannula provided superior results to low-flow oxygen delivery in moderate to severe bronchiolitis. Acta Paediatr. 2016 Aug;105(8):e368-72. doi: 10.1111/apa.13444. Epub 2016 May 16. Erratum In: Acta Paediatr. 2017 Jan;106(1):185.</citation>
    <PMID>27102726</PMID>
  </reference>
  <reference>
    <citation>American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.</citation>
    <PMID>17015575</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bambino Gesù Hospital and Research Institute</investigator_affiliation>
    <investigator_full_name>Emanuele Rossetti</investigator_full_name>
    <investigator_title>md</investigator_title>
  </responsible_party>
  <keyword>continous positive airway pressure</keyword>
  <keyword>helmet</keyword>
  <keyword>non invasive</keyword>
  <keyword>positive end expiratory pressure</keyword>
  <keyword>severe bronchiolitis</keyword>
  <keyword>pediatric intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977585
org study id: 1239_OPBG_2016
nct id: NCT02977585
lead sponsor: 
has dmc: No
Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign
      to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients
      enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25
      patients at least.

        -  10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU
           admission (random 1)

        -  5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and
           respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2
           occurs in the following first hour after Helmet CPAP treatment start, patients enrolled
           will receive endotracheal intubation, full face mask non invasive ventilation or higher
           peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.

      In investigator's experience, early worsening of severe bronchiolitis in PICU in the first
      hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.
INTRODUCTION

      Newborns and infants with severe bronchiolitis admitted in PICU (Pediatric Intensive Care
      Unit) are patients at high risk for invasive mechanical ventilation support. In current
      literature, there is lack of multicenter, prospective and randomized studies to assess and
      describe the impact of non invasive ventilation support among severe bronchiolitis admitted
      in PICU, notwithstanding the actual improvement of non invasive ventilation technique on
      intubation rate reduction.

      Recently, we can find studies on bronchiolitis management in pediatric ward and supported
      with high flow nasal cannula (HFNC).

      The studies on severe bronchiolitis admitted in PICU do not evaluate positive end expiratory
      pressure (Peep) level applied during Helmet continous positive airway pressure (CPAP)
      support.

      According to Italian PICU Network (TIPNET) data, severe bronchiolitis admitted in PICU
      intubation rate is close to 10% (report 2010-2016), whatever non invasive ventilation support
      has been used.

      Principal investigators have performed a retrospective and cohort chart review among severe
      bronchiolitis (82) admitted in PICU from 2011 to 2015. Early Helmet CPAP was applied to
      patients, but peep level has been provided according to clinician experience, because of lack
      of indication on this issue. Patients were admitted in PICU from Emergency department,
      pediatric ward and up to 72 hours of ineffective HFNC support. The investigators have studied
      intubation rate, length of stay, bronchiolitis severity score, virus infection, peep level
      and gas flow applied on Helmet CPAP.

      According to preliminary results, 10 cmH2O peep level results 50 time more protective than
      lower (5-7.5 cmH2O) peep among flow rate of 50 L/min.

      Intubation rate with peep level 10 cmH2O was 3%, while it rose over 15% among 7.5-5 cmH2O
      peep level. Statistically significant difference were found on length of PICU stay.

      Scientific literature on Helmet CPAP noising exposure is poor. Such noising was proved to be
      reduced with filter application on Helmet CPAP respiratory circuit. There are not report, and
      we have never experienced acoustic system impairment in patients undergone Helmet CPAP.

      AIMS Primary aim: to evaluate escalation therapy (higher peep, non invasive ventilation in
      pressure support mode, or intubation and mechanical ventilation) rate on severe bronchiolitis
      admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 cmH2O peep
      level in group 1, and 5 cmH2O peep level in group 0.

      Secondary aim: to evaluate, among two study groups, length of PICU stay, pneumothorax
      incidence on Helmet CPAP, sedation effect during Helmet CPAP, early enteral feeding
      tolerance, syncytial and other respiratory virus incidence, bacterial infection and 30 days
      outcome.

      DESIGN Prospective, randomized, cohort, controlled and multicentric study.

      Population: sample size The study requires 488 patients, enrolled among 20 national and
      international PICU. Sample size have been calculated on preliminary results of our
      retrospective chart review; we hypothesize that intubation rate with 5 cmH2O peep level is
      15% and application of 10 cmH2O peep level may reduce it to 50%. According to these
      hypothesis, we need 244 patients for each group to have 5% of significativity level and 80%
      of study power.

      Length of study 24 months

      Procedure and methods

      Selection and patient enrollment Severe bronchiolitis admitted in PICU and requiring
      respiratory support.

      Intervention

      Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign
      to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients
      enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25
      patients at least.

        -  10 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 1)

        -  5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and
           respiratory worsening, reduction of pH or PaO2/FiO2 occurs in the following first hour
           after Helmet CPAP treatment start, patients enrolled will receive endotracheal
           intubation, full face mask non invasive ventilation or higher peep level treatment
           (7.5-10 cmH2O) according to clinical evaluation, if necessary.

      In investigators' experience, early worsening of severe bronchiolitis in PICU in the first
      hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.

      STUDY PLAN Application of a standard treatment protocol for all patients enrolled. It is the
      same standard of care applied to treat these patients in our PICU in the last 2 years. Of
      course, patients who will not be enrolled in the study will be supported and treated with the
      best feasible care.

        -  Registration of the modified Wood's Clinical Asthma score (mWCAS) for severe
           bronchiolitis admitted in PICU (Bronchiolitis Severity Score-BSS)

        -  clarithromycin prophylaxis for newborns (up to 30 days old), or I generation
           cephalosporine for older infants, if high fever, lung opacities or high inflammation
           markers occurs (PCR, procalcitonin, White body cells)

        -  volume replacement (20 ml/kg of sodium chloride solution or albumine 5%) in 60 min

        -  morphine ev bolus: 20 mcg/kg in 2 min and following 5 mcg/kg/h infusion (or other
           sedatives according to local PICU investigator)

        -  nasogastric tube placement and early enteral feeding 4-6 hours after admission (5-10
           ml/h)

        -  desamethasone 0.2 mg/kg x3/die ev (according to local PICU investigator ).

        -  proton pump inhibitors or H2 receptor antagonist (according to local PICU investigator).

        -  aerosol therapy 4 time/die: sodium chloride hypertonic solution 3% (or sodium chloride
           0.9%) 2 ml with ipratropium bromide .

        -  Arterial blood gas exam (ABE) before Helmet CPAP application and in the following 1,12
           24, and 48 hours; arterial catheter positioning is preferred (or arterial blood sampling
           by direct arterial puncture according to local PICU practice).

        -  Pharyngeal swab for molecular analysis to detect viral DNA will be performed on PICU
           admission, if not yet performed.

        -  occipital and neck skin protection will be used to avoid Helmet CPAP pressure sores.

        -  each Helmet will be provided of a filter to reduce noise inside it.

        -  Helmet gas will flow through heat-moisture device switched on 5 min/hour

      Only patients whose parents have signed written informed consent will be enrolled in this
      study. Any direct follow up is supposed after PICU discharge. Monitoring of hospital
      discharge will be followed by intranet database of the participant hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: incidence of intubation following Helmet CPAP treatment
time frame: 7 days
description: to evaluate intubation rate on severe bronchiolitis admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 peep level in group 1, and 5 peep level in group 0.
measure: incidence of pneumothorax following Helmet CPAP treatment
time frame: 72 hours
description: pneumothorax occurrence
measure: length of stay
time frame: days 30
description: length of PICU stay
arm group label: group 1
arm group type: Active Comparator
description: high level support
arm group label: group 0
arm group type: No Intervention
description: low level support
intervention type: Device
intervention name: 10 cmH2O peep
description: positive end expiratory pressure
arm group label: group 1
criteria: 
gender: All
minimum age: 38 Weeks
maximum age: 18 Months
healthy volunteers: No
facility: 
country: Italy
citation: Donlan M, Fontela PS, Puligandla PS. Use of continuous positive airway pressure (CPAP) in acute viral bronchiolitis: a systematic review. Pediatr Pulmonol. 2011 Aug;46(8):736-46. doi: 10.1002/ppul.21483. Epub 2011 May 26.
PMID: 21618716
citation: Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.
PMID: 24612137
citation: Trevisanuto D, Camiletti L, Doglioni N, Cavallin F, Udilano A, Zanardo V. Noise exposure is increased with neonatal helmet CPAP in comparison with conventional nasal CPAP. Acta Anaesthesiol Scand. 2011 Jan;55(1):35-8. doi: 10.1111/j.1399-6576.2010.02356.x. Epub 2010 Nov 15.
PMID: 21077846
citation: Chidini G, Piastra M, Marchesi T, De Luca D, Napolitano L, Salvo I, Wolfler A, Pelosi P, Damasco M, Conti G, Calderini E. Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT. Pediatrics. 2015 Apr;135(4):e868-75. doi: 10.1542/peds.2014-1142. Epub 2015 Mar 16.
PMID: 25780074
citation: Ganu SS, Gautam A, Wilkins B, Egan J. Increase in use of non-invasive ventilation for infants with severe bronchiolitis is associated with decline in intubation rates over a decade. Intensive Care Med. 2012 Jul;38(7):1177-83. doi: 10.1007/s00134-012-2566-4. Epub 2012 Apr 18.
PMID: 22527081
citation: Milani GP, Plebani AM, Arturi E, Brusa D, Esposito S, Dell'Era L, Laicini EA, Consonni D, Agostoni C, Fossali EF. Using a high-flow nasal cannula provided superior results to low-flow oxygen delivery in moderate to severe bronchiolitis. Acta Paediatr. 2016 Aug;105(8):e368-72. doi: 10.1111/apa.13444. Epub 2016 May 16. Erratum In: Acta Paediatr. 2017 Jan;106(1):185.
PMID: 27102726
citation: American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
PMID: 17015575
responsible party type: Principal Investigator
investigator affiliation: Bambino Gesù Hospital and Research Institute
investigator full name: Emanuele Rossetti
investigator title: md
mesh term: Bronchiolitis
mesh term: Critical Illness
sharing ipd: Undecided