Clinical trial NCT01777347: Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis
Official title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Viral Bronchiolitis
Keywords: Keywords provided by ASSISTANCE PUBLIQUE HOPITAUX DE PARIS:
Acute Viral bronchiolitis
Hypertonic saline
Hospitalization
Infants
Hospital admissions
Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Virus Diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 778
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).

Detailed description: Acute viral bronchiolitis remains a significant cause of hospitalization and to date, no treatment reduce the rate of hospitalization. The only accepted treatment for bronchiolitis is nasal cleaning, hydration and for hospitalized hypoxemic infants, oxygen administration.

Several studies shown that nebulization of hypertonic saline solution reduce length of stay in hospital for hospitalized infant but effect on rate of hospitalization remains unclear.

The investigators propose a randomized double blind multicenter clinical trial on infants 6 weeks to 12 months old with moderate or severe bronchiolitis, in 21 emergency departments of hospitals situated France, during 2 winter seasons.

The investigators hypothesize that infants with bronchiolitis treated with nebulized hypertonic 3% saline solution would have less risk of being hospitalized. Our principal objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate 24 hours after treatment compared to placebo.

Secondary objectives are to compare between groups intensity of respiratory symptoms measured by RDAI clinical score, duration of symptoms, length of hospital stay for hospitalized infants, adverse effects and health care utilization.

Patients presenting to the Emergency Department with a diagnosis of moderately severe bronchiolitis will be approached for entry into the study. After the initial routine assessment, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion 4 ml of nebulized study solution either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 2 doses. After an observation period of 20 minutes following the last dose, the infant will be reassessed by the attending physician in the ER for disposition (admit, discharge home). All subsequent therapy, if needed, will be at the sole discretion of the attending physician. The family of each recruited subject will be contacted by phone 2, 7, 14 and 28 days later to assess resolution of symptoms.

Clinical response to the above treatment will also be determined independently by the study physician utilizing a standardized respiratory scoring system, the Respiratory Distress Assessment Instrument (RDAI), at study entry and after each nebulization. The primary outcome measure is the rate of admission to hospital between the study and control groups 24 hours after inclusion. Secondary outcomes measure will involve the assessment of change in the RDAI between study entry and post-treatment, adverse effects, length of stay for hospitalized infant and health care utilization.

Eligibility criteria: Inclusion Criteria:

* Age 6 weeks through 12 months
* First moderate to severe episode of acute viral bronchiolitis (history of viral upper respiratory tract infection plus wheezing and/or crackles on chest auscultation with respiratory distress ).
* Admission in Emergency Department
* Parental/guardian permission (informed consent)

Exclusion Criteria:

* prematurity \< 37 weeks
* artificial ventilation in the neonatal period
* Chronic lung or heart disease
* history of immunodeficiency
* past use of nebulized HS
* initial need for intensive care of assisted ventilation
* Non-French speaking parent/guardian

Primary outcomes:
measure: Admission rate
timeFrame: 24 hours
Secondary outcomes:
measure: change in RDAI score
timeFrame: 2 hours
measure: Number of Participants with Adverse Events
timeFrame: 2 hours
measure: length of hospitalization for hospitalized infant
timeFrame: 1 month
measure: health care utilisation
timeFrame: 1 month
Other outcomes:
Locations:
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Boulogne
country: France
facility: Hôpital Ambroise Paré
city: Caen
country: France
facility: CHU
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Colombes
country: France
facility: Hôpital Louis Mouriez
city: Corbeil
country: France
facility: Centre Hospitalier Sud Francilien
city: Créteil
country: France
facility: Centre Hospitalier intercommunal de Créteil
city: Fontainebleau
country: France
facility: Centre Hospitalier de Fontainebleau
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Kremlin Bicêtre
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
city: Limoges
country: France
facility: Hôpital Hôpital Mère Enfants
city: Lyon
country: France
facility: Hôpital Hôpital Femme Mère Enfants
city: Marseille
country: France
facility: Hôpital Nord
city: Nancy
country: France
facility: Hôpital d'enfants
city: Nantes
country: France
facility: Hôpital Mère - Enfants
city: Nice
country: France
facility: CHU Lenval
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Paris
country: France
facility: Hôpital Robert Debré
city: Rouen
country: France
facility: Hôp Charles Nicolle - CHU Rouen
city: Toulouse
country: France
facility: Hôpital des enfants
city: Versailles
country: France
facility: André Mignot
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris - Paris Sud Medical School
name: Vincent Gajdos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Angoulvant F, Bellettre X, Milcent K, Teglas JP, Claudet I, Le Guen CG, de Pontual L, Minodier P, Dubos F, Brouard J, Soussan-Banini V, Degas-Bussiere V, Gatin A, Schweitzer C, Epaud R, Ryckewaert A, Cros P, Marot Y, Flahaut P, Saunier P, Babe P, Patteau G, Delebarre M, Titomanlio L, Vrignaud B, Trieu TV, Tahir A, Regnard D, Micheau P, Charara O, Henry S, Ploin D, Panjo H, Vabret A, Bouyer J, Gajdos V; Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) Study Group. Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171333. doi: 10.1001/jamapediatrics.2017.1333. Epub 2017 Aug 7.