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Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01944995
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : September 18, 2013
Last Update Posted : August 28, 2014
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is also more and more used in infants with severe acute bronchiolitis. There is no evidence that nCPAP improves outcome, but several studies showed that it reduces work of breathing (WOB), improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP) therapy, also used in neonatal units, has recently been suggested for bronchiolitis management. This technique allows warmed and moist gas administration protecting nasal mucosa, and preventing variations of inspired gas FiO2. HFNP also creates a continuous positive pressure, reducing WOB, and seems much more comfortable and better tolerated by babies than nCPAP. There are no studies comparing both techniques for bronchiolitis management. The main objective of this study is to compare WOB with nCPAP and HFNP therapy in infants with severe bronchiolitis in pediatric intensive care unit. Secondary purpose is to compare efficacy and tolerance of both techniques. We propose to lead an open, single center, crossover randomized study. Each patient will receive the two treatments. Three consecutive periods will be studied: first one (minimum 2 hours), with the first technique CPAP or HFNP according to randomization (treatment 1); second period (2 hours) with the second technique (treatment 2); Third period (6 hours) with the second technique. The primary endpoint will be the comparison of WOB (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of the two firsts periods. Efficacy and tolerance of each technique will be evaluated and compared by compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2, modified Wood score, and EDIN score during the third period. Nine subjects by groups are required.

Condition or disease Intervention/treatment Phase
Bronchiolitis Device: glasses broadband Device: nasal CPAP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis
Study Start Date : September 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: group B Device: glasses broadband
Device: nasal CPAP
Experimental: group A Device: glasses broadband
Device: nasal CPAP

Primary Outcome Measures :
  1. calculation of the trans-diaphragmatic pressure [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. the effectiveness of treatments [ Time Frame: 12 months ]
    • respiratory and hemodynamic parameters: ( Respiratory rate; Heart Rate; blood pressure; Clinical signs of struggle)
    • haematosis ( SpO2 ; FiO2 ; transcutaneous PCO2 )

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants less than 3 months
  • Infants hospitalized in the pediatric intensive care unit of the hospital in northern Marseille for an episode of acute viral bronchiolitis, defined by the French consensus conference of 2000 (1) clinical signs of infection of the upper airways with tachypnea, brake expiratory and / or wheezing auscultation, signs of struggle
  • Infants with acute respiratory distress score with Wood changed> 3 and requiring ventilatory Support
  • Infants whose parents or legal guardians have accepted their participation in the research and signed informed consent.
  • With Social Security

Exclusion Criteria:

  • - Clinical condition requiring immediate intubation before the start of treatment to the:

    • severity of respiratory distress: FiO2> 60% to maintain SpO2> 92%
    • hemodynamic instability
    • the occurrence of apneas désaturantes (respiratory pauses greater than 20 seconds duration associated with desaturation <80% and / or bradycardia <80/min)
    • the presence of neurological disorders with altered consciousness
  • Presence of co-morbidities:

    • chronic respiratory failure
    • heart

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01944995

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Contact: fabrice michel

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Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: fabrice MiCHEL   
Principal Investigator: fabrice michel         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01944995    
Other Study ID Numbers: 2012-A01524-39
2012-36 ( Other Identifier: AP HM )
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections