NCT01777347

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
778

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

November 14, 2012

Last Update Submit

July 25, 2014

Conditions

Acute Viral Bronchiolitis

Keywords

Keywords provided by ASSISTANCE PUBLIQUE HOPITAUX DE PARIS:Acute Viral bronchiolitisHypertonic salineHospitalizationInfantsHospital admissionsAdditional relevant MeSH terms:BronchiolitisBronchiolitis, ViralBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory Tract InfectionsVirus Diseases

Outcome Measures

Primary Outcomes (1)

  • Admission rate

    24 hours

Secondary Outcomes (4)

  • change in RDAI score

    2 hours

  • Number of Participants with Adverse Events

    2 hours

  • length of hospitalization for hospitalized infant

    1 month

  • health care utilisation

    1 month

Study Arms (2)

3% Saline

EXPERIMENTAL

Nebulized 3% Saline

Drug: 3% Saline

0.9% Normal Saline

PLACEBO COMPARATOR

Nebulized 0.9% normal saline

Drug: 0.9% Normal Saline

Interventions

3% SalineDRUG

Two 4 mL nebulization of 3% saline with 20 minutes interval

Also known as: 3% Hypertonic Saline Solution for Inhalation (Mucoclear 3%)
3% Saline
0.9% Normal SalineDRUG

Two 4 mL nebulization of 0.9% normal saline with 20 minutes interval

Also known as: 0.9% Saline Solution for Inhalation
0.9% Normal Saline

Eligibility Criteria

Age6 Weeks - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Hôpital Jean Verdier

Bondy, 93140, France

Location

Hôpital Ambroise Paré

Boulogne, 92100, France

Location

CHU

Caen, France

Location

Hôpital Antoine Béclère

Clamart, 92141, France

Location

Hôpital Louis Mouriez

Colombes, France

Location

Centre Hospitalier Sud Francilien

Corbeil, 91100, France

Location

Centre Hospitalier intercommunal de Créteil

Créteil, 94000, France

Location

Centre Hospitalier de Fontainebleau

Fontainebleau, 77305, France

Location

Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, France

Location

Hôpital Jeanne de Flandre

Lille, France

Location

Hôpital Hôpital Mère Enfants

Limoges, France

Location

Hôpital Hôpital Femme Mère Enfants

Lyon, France

Location

Hôpital Nord

Marseille, France

Location

Hôpital d'enfants

Nancy, France

Location

Hôpital Mère - Enfants

Nantes, France

Location

CHU Lenval

Nice, France

Location

Hôpital Necker-Enfants Malades

Paris, 75007, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Hôp Charles Nicolle - CHU Rouen

Rouen, 76000, France

Location

Hôpital des enfants

Toulouse, France

Location

André Mignot

Versailles, France

Location

Related Publications (1)

  • 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.

    PMID: 28586918DERIVED

MeSH Terms

Conditions

BronchiolitisBronchiolitis, ViralBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory Tract InfectionsVirus Diseases

Interventions

Sodium ChlorideSaline Solution, HypertonicInhalationSaline Solution

Condition Hierarchy (Ancestors)

BronchitisInfectionsLung Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHypertonic SolutionsSolutionsPharmaceutical PreparationsRespiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaCrystalloid SolutionsIsotonic Solutions

Study Officials

  • Vincent Gajdos, MD, PhD

    Assistance Publique Hôpitaux de Paris - Paris Sud Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

January 28, 2013

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

FR(21)