Clinical trial NCT02538458: Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiolitis
Keywords: Saline Solution, Hypertonic (3 %)
Infant
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: AGIR à Dom
First posted: 2015-09-02
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wang score after 72 hours of treatment
timeFrame: 72 hours
Secondary outcomes:
measure: Recovery time
timeFrame: From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital)
measure: To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation
timeFrame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
measure: To assess average time of Oxygen therapy
timeFrame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
measure: To assess average time of Tube feeding
timeFrame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
measure: To determine variation of Wang score during hospitalisation
timeFrame: measured at Day 1, 2, 3, 4 and day of discharge.
measure: To determine percentage of patient with Adverse Event
timeFrame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Hôpital Couple Enfant
Study officials:
affiliation: University Hospital, Grenoble
name: Catherine BARBIER, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.