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Early Halt of a Randomized Controlled Study with 3% Hypertonic Saline in Acute Bronchiolitis.

Carsin, Ania; Sauvaget, Emilie; Bresson, Violaine; Retornaz, Karine; Cabrera, Maria; Jouve, Elisabeth; Truillet, Romain; Bosdure, Emmanuelle; Dubus, Jean-Christophe.
Respiration; 94(3): 251-257, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28647745

BACKGROUND:

Albeit not recommended because of contradictory results, nebulized 3% hypertonic saline is widely used for treating acute viral bronchiolitis. Whether clinical differences may be attributed to the type of nebulizer used has never been studied.

OBJECTIVES:

By modifying the amount of salt deposited into the airways, the nebulizer characteristics might influence clinical response.

METHODS:

A prospective, randomized, controlled trial included infants hospitalized in a French university hospital for a first episode of bronchiolitis. Each child received 6 nebulizations of 3% hypertonic saline during 48 h delivered with 1 of the 3 following nebulizers: 2 jet nebulizers delivering large or small particles, with a low aerosol output, and 1 mesh nebulizer delivering small particles, with a high aerosol output. The primary endpoint was the difference in the Wang score at 48 h.

RESULTS:

Only 61 children of 168 were recruited before stopping this study because of severe adverse events (n = 4) or parental requests for discontinuation due to discomfort to their child during nebulization (n = 2). One minor adverse event was noted in 91.8% (n = 56/61) of children. A high aerosol output induced 75% of the severe adverse events; it was significantly associated with the nebulization-induced cough between 24 and 48 h (p = 0.036). Decreases in Wang scores were not significantly different between the groups at 48 h, 9 recoveries out of 10 being obtained with small particles.

CONCLUSION:

No beneficial effects and possibly severe adverse events are observed with 3% hypertonic saline in the treatment of bronchiolitis.
Selo DaSilva