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Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02977585
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : January 16, 2019
Information provided by (Responsible Party):
Emanuele Rossetti, Bambino Gesù Hospital and Research Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Critically Ill Severe Bronchiolitis Device: 10 cmH2O peep Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Study Start Date : November 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Active Comparator: group 1
high level support
Device: 10 cmH2O peep
positive end expiratory pressure

No Intervention: group 0
low level support

Primary Outcome Measures :
  1. incidence of intubation following Helmet CPAP treatment [ Time Frame: 7 days ]
    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.

  2. incidence of pneumothorax following Helmet CPAP treatment [ Time Frame: 72 hours ]
    pneumothorax occurrence

Secondary Outcome Measures :
  1. length of stay [ Time Frame: days 30 ]
    length of PICU stay

Information from the National Library of Medicine

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Ages Eligible for Study:   38 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients of 38 weeks of gestational age up to 18 months old, admitted in PICU for severe bronchiolitis, whose parents have signed written informed consent to enroll the child in the study.
  • Patients with severe bronchiolitis moved from emergency department, pediatric ward, and supported up to 72 hours with HFNC or O2 therapy.

Exclusion Criteria:

  • Severe congenital malformation Inborn congenital error Neonatal or postnatal neurologic disorder Parents refusal to study participation Presence or supposed pneumothorax on chest X-ray or lung ultrasound

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02977585

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Bambino Gesù Children's Hospital Recruiting
Rome, Lazio, Italy, 00100
Contact: emanuele rossetti, md    3478370026 ext 0039   
Contact    3478370026 ext 0039   
Principal Investigator: emanuele rossetti, md         
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute

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Responsible Party: Emanuele Rossetti, md, Bambino Gesù Hospital and Research Institute Identifier: NCT02977585    
Other Study ID Numbers: 1239_OPBG_2016
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Emanuele Rossetti, Bambino Gesù Hospital and Research Institute:
continous positive airway pressure
non invasive
positive end expiratory pressure
severe bronchiolitis
pediatric intensive care unit
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections