Clinical trial NCT03619499: Non Invasive Ventilation in Bronchiolitis
Official title: Non Invasive Ventilation Versus Invasive Ventilation in Management of Bronchiolitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Invasive Ventilation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: decrease risk of respiratory failure
timeFrame: 2 days
Secondary outcomes:
measure: decrease length of hospital stay
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
citation: Mathew JL. What works in bronchiolitis? Indian Pediatr. 2009 Feb;46(2):154-8. No abstract available.
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.
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.
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.
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: 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.
citation: 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.
citation: 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.
citation: 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.