Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
* Treatment by inhalation of 3 % hypertonic saline, up to 24H. * followed by 48h of placebo : isotonic saline inhalation. Placebo control group.
Hôpital Couple Enfant
Grenoble, France
Wang score after 72 hours of treatment
Time frame: 72 hours
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.
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)
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
Time frame: 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
Time frame: 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.
Time frame: 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,
Time frame: 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
Time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
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