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NCT Number: NCT00513890

Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis

The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton, England]) during bronchiolitis of the infant compared to a conventional managment.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Dyspnea Infections Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service réanimation Pédiatrique

Montpellier, Languedoc-Roussillon, 34000, France

About this study

  • Experimental plan: The infants (0 to 6 month) admitted in pediatric intesive care unit for respiratory distress with bronchiolitis but not requiring mechanical ventilation are randomized in two groups: group "A" is treated with a non-invasive ventilation device(Infantflow) during 6 hours, group "B" is treated conventionally by inhalation of a Air/O2 mixture during 6 hours.
  • Outcome: Primary outcome: clinical score of respiratory distress at H0 and H6. Secondary outcome: respiratory and cardiac frequency, average blood pressure. Manometric: Variation of esophageal pressure at H0, H6. Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94 and 98%, transcutaneus PCO2, PaO2/FiO2
  • Analyze results: Intention to treat analysis after having checked the randomization by comparing clinical gravity in the two arms (clinical score).
  • Calendar of the study: October 2006 at April 2008
  • Follow-up of the patients: the study proceeds during the hospitalization of the infants during 6 hours and will not impose any specific follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infant from 0 to 6 months admitted in the PICU
  • Clinical diagnosis: bronchiolitis
  • Signs of respiratory distress evaluated with a clinical score of respiratory distress > 4

Exclusion criteria

  • Cardiopathy, cystic fibrosis or a neuromuscular desease
  • Need for mechanical ventilation

Treatment and study plan

Infantflow [EME, Brighton, England]

Device

Primary outcomes

  1. Clinical score of respiratory distress at base line (H0) and at 6 hours (H6)

  2. after the begining of the procedure.

  3. The respiratory distress was evaluated with the modified Woods Clinical Asthma

  4. Score (m-WCAS) [Hollman G, Shen G, Zeng L, et al. Crit Care Med 1998; 26:1731-1736]

Secondary outcomes

  1. Clinical items: respiratory and cardiac rate, average blood pressure at H0 and H6.

  2. Manometric: Variation of esophageal pressure at H0 and H6.

  3. Gasometric: Minimal FiO2 necessary to reach an oxygen saturation between 94

  4. and 98%, transcutanée PCO2, PaO2/FiO2

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis Who Didn't Require Mechanical Ventilation

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 9, 2007
Registry last updated
Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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