Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis

Acute Viral Bronchiolitis Clinical Trial

— GUERANDE  

Official title:

3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777347
• Other study ID #: IDRCB 2012-A00228-35
• Secondary ID: P110143AOM11036
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2012
• Last updated: July 25, 2014
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 778
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Weeks to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Drug:
• 3% Saline
Two 4 mL nebulization of 3% saline with 20 minutes interval
• 0.9% Normal Saline
Two 4 mL nebulization of 0.9% normal saline with 20 minutes interval

Locations

Country	Name	City	State
France	Hôpital Jean Verdier	Bondy
France	Hôpital Ambroise Paré	Boulogne
France	CHU	Caen
France	Hôpital Antoine Béclère	Clamart
France	Hôpital Louis Mouriez	Colombes
France	Centre Hospitalier Sud Francilien	Corbeil
France	Centre Hospitalier intercommunal de Créteil	Créteil
France	Centre Hospitalier de Fontainebleau	Fontainebleau
France	Hôpital Kremlin Bicêtre	Le Kremlin Bicêtre
France	Hôpital Jeanne de Flandre	Lille
France	Hôpital Hôpital Mère Enfants	Limoges
France	Hôpital Hôpital Femme Mère Enfants	Lyon
France	Hôpital Nord	Marseille
France	Hôpital d'enfants	Nancy
France	Hôpital Mère - Enfants	Nantes
France	CHU Lenval	Nice
France	Hôpital Necker-Enfants Malades	Paris
France	Hôpital Robert Debré	Paris
France	Hôp Charles Nicolle - CHU Rouen	Rouen
France	Hôpital des enfants	Toulouse
France	André Mignot	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission rate		24 hours
Secondary	change in RDAI score		2 hours
Secondary	Number of Participants with Adverse Events		2 hours
Secondary	length of hospitalization for hospitalized infant		1 month
Secondary	health care utilisation		1 month