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Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants (BRONDUSAL)

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 2015 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02538458
First Posted: September 2, 2015
Last Update Posted: September 2, 2015
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.
Collaborator:
AGIR à Dom
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose
Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

Condition Intervention Phase
Bronchiolitis Drug: 3 % hypertonic saline up to 72H Drug: 3 % hypertonic saline up to 24H Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Wang score after 72 hours of treatment [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • Recovery time [ Time Frame: From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital) ]
    Secondary outcomes will be assessed during the hospital stay for acute bronchiolitis, from inclusion date until day of hospital discharge, within 2 weeks.

  • To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation [ Time Frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital) ]
    Percentage of patient needing transfer to the PICU or use of mechanical ventilation

  • To assess average time of Oxygen therapy [ Time Frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital) ]
    average time of Oxygen therapy in days

  • To assess average time of Tube feeding [ Time Frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital) ]
    average time of Tube feeding in days.

  • To determine variation of Wang score during hospitalisation [ Time Frame: measured at Day 1, 2, 3, 4 and day of discharge. ]
    Wang score,

  • To determine percentage of patient with Adverse Event [ Time Frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital) ]
    percentage of patient with Adverse Event


Estimated Enrollment: 160
Study Start Date: November 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test group
3 % hypertonic saline up to 72H.
Drug: 3 % hypertonic saline up to 72H
Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
Other Name: 3 % hypertonic saline
Placebo Comparator: Placebo control group
  • 3 % hypertonic saline up to 24H.
  • Followed by 48 hours of placebo (nebulized 0.9% normal saline).
Drug: 3 % hypertonic saline up to 24H
  • Treatment by inhalation of 3 % hypertonic saline, up to 24H.
  • followed by 48h of placebo : isotonic saline inhalation. Placebo control group.
Other Name: palcebo

Detailed Description:
In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress
  • Winter epidemic period from November, the 15th, to March the 15th
  • Age < 12 months
  • Admission Wang score included between 4 and 8
  • Infant hospitalized for gravity clinical criteria of severity
  • Nebulized 3 % hypertonic saline treatment since less than 24 hours
  • Infant with social security card coverage
  • Free consent of at least one of the parental authority holder

Exclusion Criteria:

  • Pulmonary, cardiac or neurologic chronic underlying disease
  • Prematurity < 32 GW
  • Asthma (3rd episode or more)
  • Admission oxygen saturation level < 85 %, Wang score ≥ 9
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02538458


Contacts
Contact: Catherine BARBIER, PHD 04 76 76 59 88 cbarbier1@chu-grenoble.fr

Locations
France
Hôpital Couple Enfant Recruiting
Grenoble, France, 38043
Contact: TOURNEGROS Caroline, ARC    04 76 76 67 30 ext + 33    CTournegros@chu-grenoble.fr   
Contact: AUDOIN Pierre, ARC    04 76 76 67 30 ext + 33    PAudoin@chu-grenoble.fr   
Principal Investigator: BARBIER Catherine, PH         
Sub-Investigator: HULLO Eglantine, PH         
Sub-Investigator: BOST BRU Cecile, PH         
Sub-Investigator: GERIN Maud, CCA         
Sub-Investigator: PIN Isabelle, PH         
Sub-Investigator: FAISANT Anne, PH         
Sub-Investigator: MICHARD LENOIR Anne-Pascale, PH         
Sub-Investigator: TARRAL Eliane, PH         
Sub-Investigator: LASFARGUE Maelys, PH         
Sub-Investigator: RUBIO Amandine, PHU         
Sub-Investigator: THOMASSIN Nadège, PH         
Sponsors and Collaborators
University Hospital, Grenoble
AGIR à Dom
Investigators
Principal Investigator: Catherine BARBIER, PHD University Hospital, Grenoble
  More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02538458     History of Changes
Other Study ID Numbers: 2014-A01335-42
First Submitted: August 5, 2015
First Posted: September 2, 2015
Last Update Posted: September 2, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Grenoble:
Saline Solution, Hypertonic (3 %)
Infant

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections


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