- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619499
Non Invasive Ventilation in Bronchiolitis
January 8, 2019 updated by: Mohammed Omran, Assiut University
Non Invasive Ventilation Versus Invasive Ventilation in Management of Bronchiolitis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: azza el tayeb
- Phone Number: 01006863277
- Email: azeltayeb@aun.edu.eg
Study Contact Backup
- Name: Ismail Lotfy
- Phone Number: 01063398967
- Email: Ismail231@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: non invasive
infants who fulfill criteria of severe bronchiolitis will be connected to non invasive ventilation
|
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.
|
No Intervention: invasive
infants who were connected to invasive mechanical ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
decrease risk of respiratory failure
Time Frame: 2 days
|
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.
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
decrease length of hospital stay
Time Frame: 7 days
|
by prevention of ventilation acquired pneumonia and barotrauma that occur from use of invasive ventilation.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
- 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.
- 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.
- 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.
- 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.
- Mathew JL. What works in bronchiolitis? Indian Pediatr. 2009 Feb;46(2):154-8. No abstract available.
- 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.
- 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.
- 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.
- 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.
- Wainwright C, Altamirano L, Cheney M, Cheney J, Barber S, Price D, Moloney S, Kimberley A, Woolfield N, Cadzow S, Fiumara F, Wilson P, Mego S, VandeVelde D, Sanders S, O'Rourke P, Francis P. A multicenter, randomized, double-blind, controlled trial of nebulized epinephrine in infants with acute bronchiolitis. N Engl J Med. 2003 Jul 3;349(1):27-35. doi: 10.1056/NEJMoa022226.
- Yanez LJ, Yunge M, Emilfork M, Lapadula M, Alcantara A, Fernandez C, Lozano J, Contreras M, Conto L, Arevalo C, Gayan A, Hernandez F, Pedraza M, Feddersen M, Bejares M, Morales M, Mallea F, Glasinovic M, Cavada G. A prospective, randomized, controlled trial of noninvasive ventilation in pediatric acute respiratory failure. Pediatr Crit Care Med. 2008 Sep;9(5):484-9. doi: 10.1097/PCC.0b013e318184989f. Erratum In: Pediatr Crit Care Med. 2008 Nov;9(6):672.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2019
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
August 2, 2018
First Posted (Actual)
August 8, 2018
Study Record Updates
Last Update Posted (Actual)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 8, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIVVIVIMOB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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