Childhood Asthma With Status AsthmaticusNCT02936778
Status Asthmaticus on the Intensive Care Prospective - STATIC PRO
An observational study of Childhood Asthma With Status Asthmaticus, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study will prospectively assess the impact and relevance of several risk factors for children with severe acute asthma (SAA) or acute wheeze that have been identified in retrospective studies. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Childhood Asthma With Status Asthmaticus
- How many people
- 221 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2016to Apr 2019
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 2-18 years admitted to a Medium Care or Paediatric Intensive Care Unit in the Netherlands, with a diagnosis of acute wheeze or SAA.
Who may be able to join
- Between 2 and 18 years of age
- Admission to a PICU for SAA or acute wheeze or admission to a MC for SAA or acute wheeze
Who cannot join
- Patient is outside of specified age range
- Down's Syndrome
- Congenital/acquired heart defect that interferes with normal SAA treatment
- Congenital/acquired airway defect (tracheomalacia/bronchomalacia)
- Primary/secondary immunodeficiency
- Pre-existing chronic pulmonary condition, known to mimic asthma: Cystic Fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans
- If both parents are not able to speak the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)
This study will prospectively assess the impact and relevance of several risk factors for children with severe acute asthma (SAA) or acute wheeze that have been identified in retrospective studies. Secondary we will assess short-term medical and psychosocial functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control group admitted to a MC for SAA/acute wheeze.
- Conditions
- Childhood Asthma With Status Asthmaticus
- Keywords
- Short-term medical and psychosocial functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PICU (= case group) | Children aged 2-18 years admitted to a Paediatric Intensive Care Unit in the Netherlands, with a diagnosis of acute wheeze or SAA. | |
| MC (= control group) | Children aged 2-18 years admitted to a Medium Care in the Netherlands, with a diagnosis of acute wheeze or SAA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze
Undertreatment is defined as: Patient is not using inhaled corticosteroids (ICS), or Patient is using ICS < 7 days (counting from moment of admission to emergency department) according to treatment plan, or Patient is not using ICS according tot treatment plan.
Measured: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
Secondary outcomes (5)
Exposure to triggers (single or combined)
Pollution/airborne particulate matter (PM10), sensitization/allergen exposure, cigarette smoke exposure (measured by cotinine in urine), presence and type of virus in upper airway tract
Measured: Within the time of admission on the PICU/MC, preferably within 24 hours
Socio-economic status
Measured: Within the time of admission on the PICU/MC
Frequency of previous asthma-related hospital admissions and/or PICU admissions.
Measured: Within the time of admission on the PICU/MC and during follow up after 3-6 months
Severity of disease, defined using the GINA criteria for stepwise management of asthma.
Measured: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
Distribution of ADRB2-receptor polymorphisms compared to non-SAA population.
Measured: Through study completion, preferably within the time of admission on the PICU/MC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Asthma With Status AsthmaticusStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, Maasstad Hospital, Amsterdam UMC, location VUmc, UMC Utrecht, University Medical Center Groningen, Amphia Hospital, Rijnstate Hospital, Tergooi Hospital, Maastricht University Medical Center, Leiden University Medical Center
- Responsible party
- Principal investigator, Matthijs de Hoog, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936778
- Sponsor's protocol ID
- NL52508.078.15
- Status last verified
- May 2019
- First submitted
- 12 Oct 2016
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Intensive Care Admission of Children With Severe Acute Wheeze or Asthma (SAA)
- ClinicalTrials.gov ID
- NCT02936778
- Acronym / sponsor ID
- NL52508.078.15
- Conditions
- Childhood Asthma With Status Asthmaticus
- Keywords
- Short-term medical and psychosocial functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center, Maasstad Hospital, Amsterdam UMC, location VUmc, UMC Utrecht, University Medical Center Groningen, Amphia Hospital, Rijnstate Hospital, Tergooi Hospital, Maastricht University Medical Center, Leiden University Medical Center
- Study start
- Aug 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 18 Oct 2016 (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.
This study will prospectively assess the impact and relevance of several risk factors for children with severe acute asthma (SAA) or acute wheeze that have been identified in retrospective studies. Secondary we will assess short-term medical and psychosocial functioning in patient (and parents) admitted to a PICU for SAA/acute wheeze versus a control group admitted to a MC for SAA/acute wheeze.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICU (= case group) | – | –Children aged 2-18 years admitted to a Paediatric Intensive Care Unit in the Netherlands, with a diagnosis of acute wheeze or SAA. |
| MC (= control group) | – | –Children aged 2-18 years admitted to a Medium Care in the Netherlands, with a diagnosis of acute wheeze or SAA. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 2-18 years admitted to a Medium Care or Paediatric Intensive Care Unit in the Netherlands, with a diagnosis of acute wheeze or SAA.
Key inclusion criteria (2 listed)
- Between 2 and 18 years of age
- Admission to a PICU for SAA or acute wheeze or admission to a MC for SAA or acute wheeze
Key exclusion criteria (7 listed)
- Patient is outside of specified age range
- Down's Syndrome
- Congenital/acquired heart defect that interferes with normal SAA treatment
- Congenital/acquired airway defect (tracheomalacia/bronchomalacia)
- Primary/secondary immunodeficiency
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
Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze
Time frame: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
Undertreatment is defined as: Patient is not using inhaled corticosteroids (ICS), or Patient is using ICS < 7 days (counting from moment of admission to emergency department) according to treatment plan, or Patient is not using ICS according tot treatment plan.
5 secondary outcomes
Exposure to triggers (single or combined)
Time frame: Within the time of admission on the PICU/MC, preferably within 24 hours
Socio-economic status
Time frame: Within the time of admission on the PICU/MC
Frequency of previous asthma-related hospital admissions and/or PICU admissions.
Time frame: Within the time of admission on the PICU/MC and during follow up after 3-6 months
Severity of disease, defined using the GINA criteria for stepwise management of asthma.
Time frame: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 months
Distribution of ADRB2-receptor polymorphisms compared to non-SAA population.
Time frame: Through study completion, preferably within the time of admission on the PICU/MC
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 23 May 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Asthma With Status Asthmaticus, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 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 23 May 2019. 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 Netherlands. 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?
Undertreatment in children admitted to a PICU with a diagnosis of SAA/acute wheeze (time frame: Within the time of admission on the PICU/MC, preferably within 48 hours and during follow up after 3-6 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 23 May 2019.