Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01777347
First received: November 14, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Acute Viral Bronchiolitis
Drug: 3% Saline
Drug: 0.9% Normal Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Admission rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in RDAI score [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
  • length of hospitalization for hospitalized infant [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • health care utilisation [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 778
Study Start Date: October 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3% Saline
Nebulized 3% Saline
Drug: 3% Saline
Two 4 mL nebulization of 3% saline with 20 minutes interval
Other Name: 3% Hypertonic Saline Solution for Inhalation (Mucoclear 3%)
Placebo Comparator: 0.9% Normal Saline
Nebulized 0.9% normal saline
Drug: 0.9% Normal Saline
Two 4 mL nebulization of 0.9% normal saline with 20 minutes interval
Other Name: 0.9% Saline Solution for Inhalation

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

Ages Eligible for Study:   6 Weeks to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777347

Locations
France
Hôpital Jean Verdier
Bondy, France, 93140
Hôpital Ambroise Paré
Boulogne, France, 92100
CHU
Caen, France
Hôpital Antoine Béclère
Clamart, France, 92141
Hôpital Louis Mouriez
Colombes, France
Centre Hospitalier Sud Francilien
Corbeil, France, 91100
Centre Hospitalier intercommunal de Créteil
Créteil, France, 94000
Centre Hospitalier de Fontainebleau
Fontainebleau, France, 77305
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 Robert Debré
Paris, France, 75019
Hôpital Necker-Enfants Malades
Paris, France, 75007
Hôp Charles Nicolle - CHU Rouen
Rouen, France, 76000
Hôpital des enfants
Toulouse, France
André Mignot
Versailles, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Vincent Gajdos, MD, PhD Assistance Publique Hôpitaux de Paris - Paris Sud Medical School
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01777347     History of Changes
Other Study ID Numbers: IDRCB 2012-A00228-35, P110143, AOM11036
Study First Received: November 14, 2012
Last Updated: July 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014