Acute Viral BronchiolitisNCT01295398
Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
A study testing nebulisations in people with Acute Viral Bronchiolitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for… Read more about this study
- Who is it for?
- Ages 28 days to 18 months
- Conditions the study is for
- Acute Viral Bronchiolitis
- What is being tested?
- nebulisations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Nov 2014
- Phase
- Interventional
- 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 28 days to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant of less than 18 months old
- infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage)
- Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
- absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
- signature of the Informed consent
- Membership in a national insurance
Who cannot join
- Refusal of the parents to participate in the study
- 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
- signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
- histories of bronchiolitis or asthma of the infant
- cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
- child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).
- Conditions
- Acute Viral Bronchiolitis
- Being tested
- nebulisations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulisationsDevice
| Study group | Role | What they receive |
|---|---|---|
| conventional jet-nebulizer | Other | (particles diameter of 4-5 µm) Receives: Device: nebulisations |
| a jet-nebulizer adapted for infants | Experimental | (particles diameter of 2-2.5 µm), Receives: Device: nebulisations |
| a mesh-nebulizer adapted for infants | Experimental | (particles diameter of 2-2.5 µm). Receives: Device: nebulisations |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
Measured: 12 months
Secondary outcomes (4)
the number of children requiring oxygen
Measured: 12 months
tolerance of the nebulisations
Measured: 12 months
the number of complications.
Measured: 12 months
the number of parenteral nutrition
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionMay 2014
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295398
- Sponsor's protocol ID
- 2010-A01237-32
- Other IDs
- 2010-24
- Status last verified
- Mar 2011
- First submitted
- 9 Feb 2011
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
- ClinicalTrials.gov ID
- NCT01295398
- Acronym / sponsor ID
- 2010-A01237-32
- Conditions
- Acute Viral Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (estimated)
- First posted
- 14 Feb 2011 (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 aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional jet-nebulizer | Other | Device: nebulisations(particles diameter of 4-5 µm) |
| a jet-nebulizer adapted for infants | Experimental | Device: nebulisations(particles diameter of 2-2.5 µm), |
| a mesh-nebulizer adapted for infants | Experimental | Device: nebulisations(particles diameter of 2-2.5 µm). |
Who may qualify
- Ages
- 28 days to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infant of less than 18 months old
- infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage)
- Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
- absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
- signature of the Informed consent
Key exclusion criteria (6 listed)
- Refusal of the parents to participate in the study
- 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
- signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
- histories of bronchiolitis or asthma of the infant
- cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
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 |
|---|---|---|
| nebulisations | Device | a jet-nebulizer adapted for infants, a mesh-nebulizer adapted for infants, conventional jet-nebulizer |
Primary outcome
the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
Time frame: 12 months
4 secondary outcomes
the number of children requiring oxygen
Time frame: 12 months
tolerance of the nebulisations
Time frame: 12 months
the number of complications.
Time frame: 12 months
the number of parenteral nutrition
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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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.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nebulisations in people with Acute Viral Bronchiolitis, run by Assistance Publique Hopitaux De Marseille at 1 site 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
the improvement of the clinical score of severity at the 48th hour between the 3 groups of children (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2014.