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

Study Overview
=================
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.

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

Conditions
-----------------
Bronchiolitis

Intervention / Treatment
-----------------
* Drug: 3 % hypertonic saline up to 72H
* Drug: 3 % hypertonic saline up to 24H


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group<br>3 % hypertonic saline up to 72H. | Drug: 3 % hypertonic saline up to 72H<br>* Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.<br>* Other names: 3 % hypertonic saline;|
| Placebo Comparator: Placebo control group<br>3 % hypertonic saline up to 24H. Followed by 48 hours of placebo (nebulized 0.9% normal saline). | Drug: 3 % hypertonic saline up to 24H<br>* Treatment by inhalation of 3 % hypertonic saline, up to 24H. followed by 48h of placebo : isotonic saline inhalation. Placebo control group.<br>* Other names: palcebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wang score after 72 hours of treatment |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | Wang score, | measured at Day 1, 2, 3, 4 and day of discharge. | 
| To determine percentage of patient with Adverse Event | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Saline Solution, Hypertonic (3 %), Infant