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

November 2, 2017 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Hôpital Couple Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • palcebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wang score after 72 hours of treatment
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital)
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
From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
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
From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
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.
From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To determine variation of Wang score during hospitalisation
Time Frame: measured at Day 1, 2, 3, 4 and day of discharge.
Wang score,
measured at Day 1, 2, 3, 4 and day of discharge.
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
From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

AGIR à Dom

Investigators

  • Principal Investigator: Catherine BARBIER, PHD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01335-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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