Effect of nebulized hypertonic saline ...
Type de document :
Article dans une revue scientifique: Article original
PMID :
URL permanente :
Titre :
Effect of nebulized hypertonic saline treatment in emergency departments on the hospitalization rate for acute bronchiolitis: a randomized clinical trial
Auteur(s) :
Angoulvant, François [Auteur]
Bellettre, Xavier [Auteur]
Milcent, Karen [Auteur]
Teglas, Jean-Paul [Auteur]
Claudet, Isabelle [Auteur]
Gras-Le Guen, Christele [Auteur]
De Pontual, Loic [Auteur]
Minodier, Philippe [Auteur]
Dubos, Francois [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Brouard, Jacques [Auteur]
Soussan-Banini, Valérie [Auteur]
Degas-Bussiere, Vanessa [Auteur]
Gatin, Amelie [Auteur]
Schweitzer, Cyril [Auteur]
Epaud, Ralph [Auteur]
Ryckewaert, Amelie [Auteur]
Cros, Pierrick [Auteur]
Marot, Yves [Auteur]
Flahaut, Philippe [Auteur]
Saunier, Pascal [Auteur]
Babe, Philippe [Auteur]
Patteau, Geraldine [Auteur]
Delebarre, Mathilde [Auteur]
Titomanlio, Luigi [Auteur]
Vrignaud, Benedicte [Auteur]
Trieu, Thanh-Van [Auteur]
Tahir, Abdelilah [Auteur]
Regnard, Delphine [Auteur]
Micheau, Pascale [Auteur]
Charara, Oussama [Auteur]
Henry, Simon [Auteur]
Ploin, Dominique [Auteur]
Panjo, Henri [Auteur]
Vabret, Astrid [Auteur]
Bouyer, Jean [Auteur]
Gajdos, Vincent [Auteur]
Bellettre, Xavier [Auteur]
Milcent, Karen [Auteur]
Teglas, Jean-Paul [Auteur]
Claudet, Isabelle [Auteur]
Gras-Le Guen, Christele [Auteur]
De Pontual, Loic [Auteur]
Minodier, Philippe [Auteur]
Dubos, Francois [Auteur]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Brouard, Jacques [Auteur]
Soussan-Banini, Valérie [Auteur]
Degas-Bussiere, Vanessa [Auteur]
Gatin, Amelie [Auteur]
Schweitzer, Cyril [Auteur]
Epaud, Ralph [Auteur]
Ryckewaert, Amelie [Auteur]
Cros, Pierrick [Auteur]
Marot, Yves [Auteur]
Flahaut, Philippe [Auteur]
Saunier, Pascal [Auteur]
Babe, Philippe [Auteur]
Patteau, Geraldine [Auteur]
Delebarre, Mathilde [Auteur]
Titomanlio, Luigi [Auteur]
Vrignaud, Benedicte [Auteur]
Trieu, Thanh-Van [Auteur]
Tahir, Abdelilah [Auteur]
Regnard, Delphine [Auteur]
Micheau, Pascale [Auteur]
Charara, Oussama [Auteur]
Henry, Simon [Auteur]
Ploin, Dominique [Auteur]
Panjo, Henri [Auteur]
Vabret, Astrid [Auteur]
Bouyer, Jean [Auteur]
Gajdos, Vincent [Auteur]
Titre de la revue :
JAMA pediatrics
Nom court de la revue :
JAMA Pediatr
Numéro :
171
Pagination :
e171333
Date de publication :
2017-08-07
ISSN :
2168-6211
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Acute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the ...
Lire la suite >Acute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the pediatric emergency department (ED). To examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis. The Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) study was a multicenter, double-blind randomized clinical trial on 2 parallel groups conducted during 2 bronchiolitis seasons (October through March) from October 15, 2012, through April 15, 2014, at 24 French pediatric EDs. Among the 2445 infants (6 weeks to 12 months of age) assessed for inclusion, 777 with a first episode of acute bronchiolitis with respiratory distress and no chronic medical condition were included. Two 20-minute nebulization treatments of 4 mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart. Hospital admission rate in the 24 hours after enrollment. Of the 777 infants included in the study (median age, 3 months; interquartile range, 2-5 months; 468 [60.2%] male), 385 (49.5%) were randomized to the HS group and 387 (49.8%) to the NS group (5 patients did not receive treatment). By 24 hours, 185 of 385 infants (48.1%) in the HS group were admitted compared with 202 of 387 infants (52.2%) in the NS group. The risk difference for hospitalizations was not significant according to the mixed-effects regression model (adjusted risk difference, -3.2%; 95% CI, -8.7% to 2.2%; P = .25). The mean (SD) Respiratory Distress Assessment Instrument score improvement was greater in the HS group (-3.1 [3.2]) than in the NS group (-2.4 [3.3]) (adjusted difference, -0.7; 95% CI, -1.2 to -0.2; P = .006) and similarly for the Respiratory Assessment Change Score. Mild adverse events, such as worsening of cough, occurred more frequently among children in the HS group (35 of 392 [8.9%]) than among those in the NS group (15 of 384 [3.9%]) (risk difference, 5.0%; 95% CI, 1.6%-8.4%; P = .005), with no serious adverse events. Nebulized HS treatment did not significantly reduce the rate of hospital admissions among infants with a first episode of acute moderate to severe bronchiolitis who were admitted to the pediatric ED relative to NS, but mild adverse events were more frequent in the HS group. clinicaltrials.gov Identifier: NCT01777347.Lire moins >
Lire la suite >Acute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the pediatric emergency department (ED). To examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis. The Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) study was a multicenter, double-blind randomized clinical trial on 2 parallel groups conducted during 2 bronchiolitis seasons (October through March) from October 15, 2012, through April 15, 2014, at 24 French pediatric EDs. Among the 2445 infants (6 weeks to 12 months of age) assessed for inclusion, 777 with a first episode of acute bronchiolitis with respiratory distress and no chronic medical condition were included. Two 20-minute nebulization treatments of 4 mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart. Hospital admission rate in the 24 hours after enrollment. Of the 777 infants included in the study (median age, 3 months; interquartile range, 2-5 months; 468 [60.2%] male), 385 (49.5%) were randomized to the HS group and 387 (49.8%) to the NS group (5 patients did not receive treatment). By 24 hours, 185 of 385 infants (48.1%) in the HS group were admitted compared with 202 of 387 infants (52.2%) in the NS group. The risk difference for hospitalizations was not significant according to the mixed-effects regression model (adjusted risk difference, -3.2%; 95% CI, -8.7% to 2.2%; P = .25). The mean (SD) Respiratory Distress Assessment Instrument score improvement was greater in the HS group (-3.1 [3.2]) than in the NS group (-2.4 [3.3]) (adjusted difference, -0.7; 95% CI, -1.2 to -0.2; P = .006) and similarly for the Respiratory Assessment Change Score. Mild adverse events, such as worsening of cough, occurred more frequently among children in the HS group (35 of 392 [8.9%]) than among those in the NS group (15 of 384 [3.9%]) (risk difference, 5.0%; 95% CI, 1.6%-8.4%; P = .005), with no serious adverse events. Nebulized HS treatment did not significantly reduce the rate of hospital admissions among infants with a first episode of acute moderate to severe bronchiolitis who were admitted to the pediatric ED relative to NS, but mild adverse events were more frequent in the HS group. clinicaltrials.gov Identifier: NCT01777347.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
CHU Lille
Université de Lille
Université de Lille
Date de dépôt :
2019-12-09T16:55:03Z