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
About this trial
This is an interventional treatment trial for Non Invasive Ventilation
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.
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
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:
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Non Invasive Ventilation in Bronchiolitis
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