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Non Invasive Ventilation in Bronchiolitis

Primary Purpose

Non Invasive Ventilation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non invasive ventilation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Invasive Ventilation

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all infants with acute severe bronchiolitis,
  • infants aged below 1 year.

Exclusion Criteria:

  • patients who have contraindications for NIV (patients with maxillofacial trauma, gastrointestinal obstruction and severe secretion),
  • Children who had suspected or confirmed underlying chronic diseases (i.e., cystic fibrosis, chronic pulmonary disease, congenital heart disease, bronchopulmonary disease, prematurity,
  • Children who had already more than one wheezing episode.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    non invasive

    invasive

    Arm Description

    infants who fulfill criteria of severe bronchiolitis will be connected to non invasive ventilation

    infants who were connected to invasive mechanical ventilation

    Outcomes

    Primary Outcome Measures

    decrease risk of respiratory failure
    in the form of ( pulse oximetry less than 94⁒, pao2 less than 60mmHg, paco2 more than 84mmHg ) while on NIV that lead to connection to invasive mechanical ventilation.

    Secondary Outcome Measures

    decrease length of hospital stay
    by prevention of ventilation acquired pneumonia and barotrauma that occur from use of invasive ventilation.

    Full Information

    First Posted
    July 24, 2018
    Last Updated
    January 8, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03619499
    Brief Title
    Non Invasive Ventilation in Bronchiolitis
    Official Title
    Non Invasive Ventilation Versus Invasive Ventilation in Management of Bronchiolitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    December 1, 2019 (Anticipated)
    Study Completion Date
    October 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is decided to perform a prospective study in a non-selected population of infants with bronchiolitis during one year ( October.2018 to October.2019) to study the characteristics, clinical course and outcome of the use of Non invasive ventilation in the management and compare the results with those treated with invasive ventilation to assess safety and efficacy and inform guideline construction.
    Detailed Description
    Acute viral bronchiolitis is one of the most common respiratory diseases in early childhood and is a major health problem worldwide. The seasonal burden of the disease, the number of hospitalizations each year and the risk of subsequent asthma bring about substantial costs in developed countries. Respiratory syncytial virus and Human Rhinovirus seem to be the most frequent etiologic agents, but other viruses such as human Metapneumovirus, Influenza virus, and Parainfluenza virus can also be involved. The spectrum of clinical outcomes is wide, but bronchiolitis is more severe when caused by Respiratory syncytial virus. In contrast, while Human Rhinovirus is involved in milder forms, it is more likely to be associated with recurrent wheezing in infancy. Acute respiratory failure from pneumonia, influenza, and respiratory syncytial virus is responsible for 4.25 million deaths world-wide and the leading cause of mortality in low and middle-income countries. In the United Kingdom up to 7% of bronchiolitis admissions require intensive care for ventilatory support. One third of unplanned infant admissions to pediatric intensive care units have respiratory failure, the majority due to bronchiolitis, require invasive mechanical ventilation for 4-7 days and a prolonged hospital stay. In countries where there is no retrieval infrastructure, the need to develop safe and effective alternatives to invasive ventilation and pediatric intensive care unit admission is acute. However, none of the interventions commonly used for infants admitted with bronchiolitis is backed by robust evidence of benefit for clinically significant outcomes, making this a pressing subject for further study. Typically, intensive respiratory support for bronchiolitis is via invasive mechanical ventilation through an artificial airway, an intervention with recognized complications in infants. There is evidence to support the use of non-invasive ventilation in pediatric acute respiratory failure of variable causes.Although evidence for use in bronchiolitis is increasing,clinical acceptance is not universal and published best practice guidelines are not easily available.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Invasive Ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    non invasive
    Arm Type
    Experimental
    Arm Description
    infants who fulfill criteria of severe bronchiolitis will be connected to non invasive ventilation
    Arm Title
    invasive
    Arm Type
    No Intervention
    Arm Description
    infants who were connected to invasive mechanical ventilation
    Intervention Type
    Device
    Intervention Name(s)
    non invasive ventilation
    Intervention Description
    patients who will fulfill the criteria of severe bronchiolitis will be connected to non invasive ventilation including continuous positive airway pressure via nasal prongs or nasal mask. Mode of ventilation, inspired oxygen levels, oxygen saturation, respiratory rate, and blood gas values from arterial samples prior to and after 2 and 4 hrs of ventilation or nearest time, will be documented.
    Primary Outcome Measure Information:
    Title
    decrease risk of respiratory failure
    Description
    in the form of ( pulse oximetry less than 94⁒, pao2 less than 60mmHg, paco2 more than 84mmHg ) while on NIV that lead to connection to invasive mechanical ventilation.
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    decrease length of hospital stay
    Description
    by prevention of ventilation acquired pneumonia and barotrauma that occur from use of invasive ventilation.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all infants with acute severe bronchiolitis, infants aged below 1 year. Exclusion Criteria: patients who have contraindications for NIV (patients with maxillofacial trauma, gastrointestinal obstruction and severe secretion), Children who had suspected or confirmed underlying chronic diseases (i.e., cystic fibrosis, chronic pulmonary disease, congenital heart disease, bronchopulmonary disease, prematurity, Children who had already more than one wheezing episode.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    azza el tayeb
    Phone
    01006863277
    Email
    azeltayeb@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ismail Lotfy
    Phone
    01063398967
    Email
    Ismail231@aun.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17848876
    Citation
    Andreola B, Bressan S, Callegaro S, Liverani A, Plebani M, Da Dalt L. Procalcitonin and C-reactive protein as diagnostic markers of severe bacterial infections in febrile infants and children in the emergency department. Pediatr Infect Dis J. 2007 Aug;26(8):672-7. doi: 10.1097/INF.0b013e31806215e3.
    Results Reference
    result
    PubMed Identifier
    22074934
    Citation
    Feuillet F, Lina B, Rosa-Calatrava M, Boivin G. Ten years of human metapneumovirus research. J Clin Virol. 2012 Feb;53(2):97-105. doi: 10.1016/j.jcv.2011.10.002. Epub 2011 Nov 9.
    Results Reference
    result
    PubMed Identifier
    20375160
    Citation
    Gern JE. The ABCs of rhinoviruses, wheezing, and asthma. J Virol. 2010 Aug;84(15):7418-26. doi: 10.1128/JVI.02290-09. Epub 2010 Apr 7.
    Results Reference
    result
    PubMed Identifier
    21700604
    Citation
    Koponen P, Helminen M, Paassilta M, Luukkaala T, Korppi M. Preschool asthma after bronchiolitis in infancy. Eur Respir J. 2012 Jan;39(1):76-80. doi: 10.1183/09031936.00040211. Epub 2011 Jun 23.
    Results Reference
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    PubMed Identifier
    19242034
    Citation
    Mathew JL. What works in bronchiolitis? Indian Pediatr. 2009 Feb;46(2):154-8. No abstract available.
    Results Reference
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    PubMed Identifier
    19240806
    Citation
    Marguet C, Lubrano M, Gueudin M, Le Roux P, Deschildre A, Forget C, Couderc L, Siret D, Donnou MD, Bubenheim M, Vabret A, Freymuth F. In very young infants severity of acute bronchiolitis depends on carried viruses. PLoS One. 2009;4(2):e4596. doi: 10.1371/journal.pone.0004596. Epub 2009 Feb 25.
    Results Reference
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    PubMed Identifier
    21852336
    Citation
    Midulla F, Pierangeli A, Cangiano G, Bonci E, Salvadei S, Scagnolari C, Moretti C, Antonelli G, Ferro V, Papoff P. Rhinovirus bronchiolitis and recurrent wheezing: 1-year follow-up. Eur Respir J. 2012 Feb;39(2):396-402. doi: 10.1183/09031936.00188210. Epub 2011 Aug 18.
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    PubMed Identifier
    20606908
    Citation
    Khilnani P, Singhi S, Lodha R, Santhanam I, Sachdev A, Chugh K, Jaishree M, Ranjit S, Ramachandran B, Ali U, Udani S, Uttam R, Deopujari S. Pediatric Sepsis Guidelines: Summary for resource-limited countries. Indian J Crit Care Med. 2010 Jan;14(1):41-52. doi: 10.4103/0972-5229.63029.
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    PubMed Identifier
    17015575
    Citation
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    Results Reference
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    PubMed Identifier
    19416146
    Citation
    Valkonen H, Waris M, Ruohola A, Ruuskanen O, Heikkinen T. Recurrent wheezing after respiratory syncytial virus or non-respiratory syncytial virus bronchiolitis in infancy: a 3-year follow-up. Allergy. 2009 Sep;64(9):1359-65. doi: 10.1111/j.1398-9995.2009.02022.x. Epub 2009 Mar 23.
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    Citation
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    Citation
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    Non Invasive Ventilation in Bronchiolitis

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