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

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
3 % hypertonic saline up to 72H
3 % hypertonic saline up to 24H
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Saline Solution, Hypertonic (3 %), Infant

Eligibility Criteria

1 Minute - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Couple Enfant

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test group

Placebo control group

Arm Description

3 % hypertonic saline up to 72H.

3 % hypertonic saline up to 24H. Followed by 48 hours of placebo (nebulized 0.9% normal saline).

Outcomes

Primary Outcome Measures

Wang score after 72 hours of treatment

Secondary Outcome Measures

Recovery time
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
Percentage of patient needing transfer to the PICU or use of mechanical ventilation
To assess average time of Oxygen therapy
average time of Oxygen therapy in days
To assess average time of Tube feeding
average time of Tube feeding in days.
To determine variation of Wang score during hospitalisation
Wang score,
To determine percentage of patient with Adverse Event
percentage of patient with Adverse Event

Full Information

First Posted
August 5, 2015
Last Updated
November 2, 2017
Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom
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1. Study Identification

Unique Protocol Identification Number
NCT02538458
Brief Title
Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants
Acronym
BRONDUSAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Saline Solution, Hypertonic (3 %), Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Active Comparator
Arm Description
3 % hypertonic saline up to 72H.
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
3 % hypertonic saline up to 24H. Followed by 48 hours of placebo (nebulized 0.9% normal saline).
Intervention Type
Drug
Intervention Name(s)
3 % hypertonic saline up to 72H
Other Intervention Name(s)
3 % hypertonic saline
Intervention Description
Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
Intervention Type
Drug
Intervention Name(s)
3 % hypertonic saline up to 24H
Other Intervention Name(s)
palcebo
Intervention Description
Treatment by inhalation of 3 % hypertonic saline, up to 24H. followed by 48h of placebo : isotonic saline inhalation. Placebo control group.
Primary Outcome Measure Information:
Title
Wang score after 72 hours of treatment
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Recovery time
Description
Secondary outcomes will be assessed during the hospital stay for acute bronchiolitis, from inclusion date until day of hospital discharge, within 2 weeks.
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)
Title
To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation
Description
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)
Title
To assess average time of Oxygen therapy
Description
average time of Oxygen therapy in days
Time Frame
From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Title
To assess average time of Tube feeding
Description
average time of Tube feeding in days.
Time Frame
From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Title
To determine variation of Wang score during hospitalisation
Description
Wang score,
Time Frame
measured at Day 1, 2, 3, 4 and day of discharge.
Title
To determine percentage of patient with Adverse Event
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine BARBIER, PHD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Couple Enfant
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31699072
Citation
Beal G, Barbier C, Thoret S, Rubio A, Bonnet M, Mazet R, Ego A, Pin I. Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial. BMC Pediatr. 2019 Nov 8;19(1):417. doi: 10.1186/s12887-019-1804-0.
Results Reference
derived

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

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