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

Sponsors

Lead sponsor: University Hospital, Grenoble

Collaborator: AGIR à Dom

Source University Hospital, Grenoble
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.

Overall Status Completed
Start Date November 2014
Completion Date March 2016
Primary Completion Date March 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Wang score after 72 hours of treatment 72 hours
Secondary Outcome
Measure Time Frame
Recovery time 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 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 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 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 measured at Day 1, 2, 3, 4 and day of discharge.
To determine 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)
Enrollment 120
Condition
Intervention

Intervention type: Drug

Intervention name: 3 % hypertonic saline up to 72H

Description: Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.

Arm group label: Test group

Other name: 3 % hypertonic saline

Intervention type: Drug

Intervention name: 3 % hypertonic saline up to 24H

Description: Treatment by inhalation of 3 % hypertonic saline, up to 24H. followed by 48h of placebo : isotonic saline inhalation. Placebo control group.

Arm group label: Placebo control group

Other name: palcebo

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

Gender: All

Minimum age: N/A

Maximum age: 12 Months

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Catherine BARBIER, PHD Principal Investigator University Hospital, Grenoble
Location
facility
Hôpital Couple Enfant
Location Countries

France

Verification Date

November 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Test group

Arm group type: Active Comparator

Description: 3 % hypertonic saline up to 72H.

Arm group label: Placebo control group

Arm group type: Placebo Comparator

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

Acronym BRONDUSAL
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov