Acute Viral BronchiolitisPhase 3GUERANDENCT01777347
Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis
A Phase 3 study testing 3% Saline and 0.9% Normal Saline in people with Acute Viral Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 21 sites in France.
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). Read more about this study
- Who is it for?
- Ages 6 weeks to 12 months
- Conditions the study is for
- Acute Viral Bronchiolitis
- What is being tested?
- 3% Saline and 0.9% Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 778 participants
- Where
- 21 sitesFrance
- Study dates
- Oct 2012to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
Hôpital Jean Verdier
Bondy, 93140
Hôpital Ambroise Paré
Boulogne, 92100
CHU
Caen
Hôpital Antoine Béclère
Clamart, 92141
Hôpital Louis Mouriez
Colombes
Centre Hospitalier Sud Francilien
Corbeil, 91100
Centre Hospitalier intercommunal de Créteil
Créteil, 94000
Centre Hospitalier de Fontainebleau
Fontainebleau, 77305
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre
Hôpital Jeanne de Flandre
Lille
Hôpital Hôpital Mère Enfants
Limoges
Hôpital Hôpital Femme Mère Enfants
Lyon
Hôpital Nord
Marseille
Hôpital d'enfants
Nancy
Hôpital Mère - Enfants
Nantes
CHU Lenval
Nice
Hôpital Necker-Enfants Malades
Paris, 75007
Hôpital Robert Debré
Paris, 75019
Hôp Charles Nicolle - CHU Rouen
Rouen, 76000
Hôpital des enfants
Toulouse
André Mignot
Versailles
About this study
Official title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial
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).
Read the 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.
- Conditions
- Acute Viral Bronchiolitis
- Being tested
- 3% Saline, 0.9% Normal Saline
- 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
- Medical subject headings
- Bronchiolitis, Bronchiolitis, Viral, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% SalineDrug
Also called 3% Hypertonic Saline Solution for Inhalation (Mucoclear 3%)
Two 4 mL nebulization of 3% saline with 20 minutes interval
0.9% Normal SalineDrug
Also called 0.9% Saline Solution for Inhalation
Two 4 mL nebulization of 0.9% normal saline with 20 minutes interval
| Study group | Role | What they receive |
|---|---|---|
| 3% Saline | Experimental | Nebulized 3% Saline Receives: Drug: 3% Saline |
| 0.9% Normal Saline | Placebo comparator | Nebulized 0.9% normal saline Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission rate
Measured: 24 hours
Secondary outcomes (4)
change in RDAI score
Measured: 2 hours
Number of Participants with Adverse Events
Measured: 2 hours
length of hospitalization for hospitalized infant
Measured: 1 month
health care utilisation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Viral BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Gajdos, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris - Paris Sud Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777347
- Sponsor's protocol ID
- IDRCB 2012-A00228-35
- Other IDs
- P110143, AOM11036
- Acronym
- GUERANDE
- Status last verified
- Jul 2014
- First submitted
- 14 Nov 2012
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28586918
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01777347
- Acronym / sponsor ID
- GUERANDE / IDRCB 2012-A00228-35
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3% Saline | Experimental | Drug: 3% SalineNebulized 3% Saline |
| 0.9% Normal Saline | Placebo comparator | Drug: 0.9% Normal SalineNebulized 0.9% normal saline |
Who may qualify
- Ages
- 6 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- prematurity < 37 weeks
- artificial ventilation in the neonatal period
- Chronic lung or heart disease
- history of immunodeficiency
- past use of nebulized HS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% SalineAlso: 3% Hypertonic Saline Solution for Inhalation (Mucoclear 3%)Two 4 mL nebulization of 3% saline with 20 minutes interval | Drug | 3% Saline |
| 0.9% Normal SalineAlso: 0.9% Saline Solution for InhalationTwo 4 mL nebulization of 0.9% normal saline with 20 minutes interval | Drug | 0.9% Normal Saline |
Primary outcome
Admission rate
Time frame: 24 hours
4 secondary outcomes
change in RDAI score
Time frame: 2 hours
Number of Participants with Adverse Events
Time frame: 2 hours
length of hospitalization for hospitalized infant
Time frame: 1 month
health care utilisation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Derived from this study: PubMed 28586918Angoulvant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gajdos, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris - Paris Sud Medical School
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3% Saline and 0.9% Normal Saline in people with Acute Viral Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.