NCT03619499

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

July 24, 2018

Last Update Submit

January 8, 2019

Conditions

Non Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 days

Secondary Outcomes (1)

  • decrease length of hospital stay

    7 days

Study Arms (2)

non invasive

EXPERIMENTAL

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

Device: non invasive ventilation

invasive

NO INTERVENTION

infants who were connected to invasive mechanical ventilation

Interventions

non invasive ventilationDEVICE

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.

non invasive

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 17848876RESULT

  • 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.

    PMID: 22074934RESULT

  • 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.

    PMID: 20375160RESULT

  • 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.

    PMID: 21700604RESULT

  • Mathew JL. What works in bronchiolitis? Indian Pediatr. 2009 Feb;46(2):154-8. No abstract available.

    PMID: 19242034RESULT

  • 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.

    PMID: 19240806RESULT

  • 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.

    PMID: 21852336RESULT

  • 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.

    PMID: 20606908RESULT

  • 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.

    PMID: 17015575RESULT

  • 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.

    PMID: 19416146RESULT

  • 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.

    PMID: 12840089RESULT

  • 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.

    PMID: 18679148RESULT

  • 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.

    PMID: 20100768RESULT

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Central Study Contacts

azza el tayeb

CONTACT

01006863277azeltayeb@aun.edu.eg

Ismail Lotfy

CONTACT

01063398967Ismail231@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 8, 2018

Study Start

March 1, 2019

Primary Completion

December 1, 2019

Study Completion

October 1, 2021

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share