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JAMA Pediatr. 2017 Aug 7;171(8):e171333. doi: 10.1001/jamapediatrics.2017.1333. Epub 2017 Aug 7.

Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis: A Randomized Clinical Trial.

Author information

1
Service d'accueil des urgences pédiatriques, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
2
Epidémiologie Clinique et Évaluation Économique Appliquées aux Populations Vulnérables, INSERM, Unité Mixte de Recherche 1123, Paris, France.
3
Service d'accueil des urgences pédiatriques, Robert Debré University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
4
Service de Pédiatrie, Antoine Béclère University Hospital, Assistance Publique-Hôpitaux de Paris, Clamart, France.
5
Centre for Research in Epidemiology and Population Health, INSERM U1018, Villejuif, France.
6
Service d'accueil des urgences pédiatriques, Toulouse University Hospital, Toulouse, France.
7
Service d'accueil des urgences pédiatriques, Nantes University Hospital, Nantes, France.
8
Service de Pédiatrie, Jean Verdier University Hospital, Assistance Publique-Hôpitaux de Paris, Bondy, France.
9
Service d'accueil des urgences pédiatriques, Marseille Nord University Hospital, Assistance Publique-Hôpitaux de Marseille, Marseille, France.
10
Service d'accueil des urgences pédiatriques, Lille University Hospital, Lille, France.
11
Service de Pédiatrie, Caen University Hospital, Caen, France.
12
Service de Pédiatrie, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris, Boulogne-Billancourt, France.
13
Service de Pédiatrie, Sud-Francilien Hospital, Corbeil-Essonnes, France.
14
Service de médecine infantile, Nancy University Hospital, Vandoeuvre-Lès-Nancy, France.
15
Service d'accueil des urgences pédiatriques, Creteil Intercommunal Hospital, Creteil, France.
16
Service d'accueil des urgences pédiatriques, Rennes University Hospital, Rennes, France.
17
Service de Pédiatrie, Brest University Hospital, Brest, France.
18
Service d'accueil des urgences pédiatriques, Tours University Hospital, Tours, France.
19
Service d'accueil des urgences pédiatriques, Rouen University Hospital, Rouen, France.
20
Service de Pédiatrie, Fontainebleau Hospital, Fontainebleau, France.
21
Service d'accueil des urgences pédiatriques, Lenval University Hospital, Nice, France.
22
Service d'accueil des urgences pédiatriques, Limoges University Hospital, Limoges, France.
23
Service d'accueil des urgences pédiatriques, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, Kremlin-Bicêtre, France.
24
Service de Pédiatrie, André Mignot Hospital, Le Chesnay, France.
25
Service de Pédiatrie, Laennec Hospital, Quimper, France.
26
Service d'accueil des urgences pédiatriques, Mother Child University Hospital, Bron, France.
27
Epidémiologie, Pharmacologie, Investigation Clinique, Information médicale, Mère-Enfant (EPICIME), Clinical Investigation Center, INSERM Clinical Investigation Center 1407, Bron, France.

Abstract

Importance:

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).

Objective:

To examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis.

Design, Setting, and Participants:

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.

Interventions:

Two 20-minute nebulization treatments of 4 mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart.

Main Outcomes and Measures:

Hospital admission rate in the 24 hours after enrollment.

Results:

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.

Conclusions and Relevance:

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.

Trial Registration:

clinicaltrials.gov Identifier: NCT01777347.

[Indexed for MEDLINE]

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