NCT00513890

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 24, 2013

Status Verified

April 1, 2012

Enrollment Period

3.3 years

First QC Date

August 8, 2007

Last Update Submit

October 23, 2013

Conditions

BronchiolitisRespiratory Distress

Keywords

BronchiolitisEsophageal pressure mesurementClinical scoreCitical careInfant

Outcome Measures

Primary Outcomes (4)

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

  • after the begining of the procedure.

  • The respiratory distress was evaluated with the modified Woods Clinical Asthma

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

Secondary Outcomes (4)

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

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

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

  • and 98%, transcutanée PCO2, PaO2/FiO2

Interventions

Infantflow [EME, Brighton, England]DEVICE

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service réanimation Pédiatrique

Montpellier, Languedoc-Roussillon, 34000, France

Location

MeSH Terms

Conditions

BronchiolitisDyspnea

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • PICAUD Jean Charles, Doctor

    Service de réanimation pédiatrique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

October 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 24, 2013

Record last verified: 2012-04

Locations

FR(1)