Asthma in ChildrenASPECTNCT03967873
Child Asthma : What Parents Attitude During an Asthma Attack at Home Before Consulting the Pediatric Emergencies
An observational study of Asthma in Children and Asthma Attack, run by University Hospital, Brest at 2 sites in France.
Trial summary
prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Asthma in Children, Asthma Attack, Therapeutic Adherence
- How many people
- 350 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Oct 2018to 30 Jun 2020
- Phase
- Observational
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children between 2 and 15 years old in Quimper or Brest emergency department for asthma attacks whose parents agree to fill in a questionnaire about their pre-hospital attitude.
Who may be able to join
- child over 2 years emergency room consultant for asthma attack
- child whose parents did not express their opposition to participate and completed the non-objection form
- child consultant in pediatric emergencies of Quimper and Brest
Who cannot join
- child whose age is not between 2 and 15 years old
- cough equivalent of asthma
- history of cardiac or pulmonary pathology or prematurity
- refusal to participate
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prevalence of Preoperative Short-acting Mimetic beta2 Therapy by Parents of Asthmatic Children Attending Emergency Room for Asthma Attack
prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home.
The main objective is to calculate the prevalence of placement of short-acting bronchodilators. The secondary objectives are to describe the factors associated with their implementation.
- Conditions
- Asthma in Children, Asthma Attack, Therapeutic Adherence
- Medical subject headings
- Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of short-acting bronchodilator induction in children attending emergency room for asthma attack
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start9 Oct 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967873
- Sponsor's protocol ID
- ASPECT (29BRC18.0201)
- Acronym
- ASPECT
- Status last verified
- Aug 2020
- First submitted
- 28 May 2019
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Preoperative Short-acting Mimetic beta2 Therapy by Parents of Asthmatic Children Attending Emergency Room for Asthma Attack
- ClinicalTrials.gov ID
- NCT03967873
- Acronym / sponsor ID
- ASPECT / ASPECT (29BRC18.0201)
- Conditions
- Asthma in Children, Asthma Attack, Therapeutic Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 May 2019 (actual)
- 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.
prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home.
The main objective is to calculate the prevalence of placement of short-acting bronchodilators. The secondary objectives are to describe the factors associated with their implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children between 2 and 15 years old in Quimper or Brest emergency department for asthma attacks whose parents agree to fill in a questionnaire about their pre-hospital attitude.
Key inclusion criteria (3 listed)
- child over 2 years emergency room consultant for asthma attack
- child whose parents did not express their opposition to participate and completed the non-objection form
- child consultant in pediatric emergencies of Quimper and Brest
Key exclusion criteria (4 listed)
- child whose age is not between 2 and 15 years old
- cough equivalent of asthma
- history of cardiac or pulmonary pathology or prematurity
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of short-acting bronchodilator induction in children attending emergency room for asthma attack
Time frame: 1 hour
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 24 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Asthma Attack, run by University Hospital, Brest at 2 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 3 inclusion and 4 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 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
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?
prevalence of short-acting bronchodilator induction in children attending emergency room for asthma attack (time frame: 1 hour). 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 24 Aug 2020.