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| Name | Class |
|---|---|
| AGIR Ã Dom | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Active Comparator | 3 % hypertonic saline up to 72H. |
|
| Placebo control group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 % hypertonic saline up to 72H | Drug | Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Wang score after 72 hours of treatment | 72 hours |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine BARBIER, PHD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Couple Enfant | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31699072 | Derived | 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. |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 3 % hypertonic saline up to 24H | Drug |
|
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| 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) |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |