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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01944995
First received: September 13, 2013
Last updated: August 27, 2014
Last verified: August 2014
  Purpose
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 Intervention
Bronchiolitis Device: glasses broadband Device: nasal CPAP

Study Type: Interventional
Study Design: 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

Further study details as provided by Assistance Publique Hopitaux De Marseille:

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

Secondary Outcome Measures:
  • 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 )


Estimated Enrollment: 18
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group B Device: glasses broadband Device: nasal CPAP
Experimental: group A Device: glasses broadband Device: nasal CPAP

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944995

Contacts
Contact: fabrice michel fabrice.michel@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: fabrice MiCHEL       fabrice.michel@ap-hm.fr   
Principal Investigator: fabrice michel         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
  More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01944995     History of Changes
Other Study ID Numbers: 2012-A01524-39
2012-36 ( Other Identifier: AP HM )
Study First Received: September 13, 2013
Last Updated: August 27, 2014

Additional relevant MeSH terms:
Bronchiolitis
Respiratory Aspiration
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Respiration Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2017