An observational study in Wheezing and Asthma in Children, sponsored by HUS Skin and Allergy Hospital. Status unknown at 2 sites in Finland. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by HUS Skin and Allergy Hospital · Observational
This study evaluates the value of impedance pneumography, used as overnight home recordings during a longitudinal design, in assessing asthma control in preschool children
Lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (PEF) or spirometry. However, indices derived from spontaneous tidal respiratory air flow and the shape of tidal expiratory flow-volume and flow-time curves relate to lung function and are easier to record even in young children. As a more advanced approach, the time dynamics and complexity properties of the tidal breathing flow volume (TBFV) signal have been analysed and found to relate to various respiratory conditions.
Impedance pneumography (IP) is a method for measuring changes in the thoracic electrical impedance through skin electrodes, which varies as a function of lung aeration i.e. breathing. Recent technical advancements have enabled IP to be used for accurate non-invasive tidal flow signal measurement. Moreover, in overnight recordings at home, IP was found feasible for quantifying nocturnal TBFV variability in young children with lower respiratory symptoms, showing that preschool children with high risk of asthma present with increased variation of tidal flow profile shape, and momentarily lowered chaoticity, compared to children with lower risk of asthma. So far, there are no studies that have addressed the utility of IP to assess asthma control in young children with asthma.
The purpose of this study is to investigate the utility of a commercially available IP device (VENTICA, Icare Finland, Finland) and IP-derived clinical indices in assessing the clinical control of asthmatic children receiving normal therapy in a longitudinal setting. The primary hypothesis is that TBFV variability quantified by IP is associated with disease control during management of young children with asthma. The secondary hypothesis is that TBFV variability quantified by IP predicts changes in disease control during management of young children with asthma.
189 studies on the registry are indexed under Respiratory Sounds; 41 are open to participants now.
This study's enrollment of 53 is below the median of 109 across 82 observational studies indexed under Respiratory Sounds.
Browse Respiratory Sounds studies →HUS Skin and Allergy Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Thirty (30) patients who have attended pediatric ward in the study centre(s) due to asthmatic symptoms (wheeze, cough, dyspnea) will be recruited.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childhood asthma control test (C-ACT)
Questionnaire that measures current asthma control, including 7 questions and a minimum score of 0 and maximum score of 27; score 19 or less indicates that asthma is not controlled.
Time frame: Weekly up to maximum 6 months or until loss of asthma control/exacerbation
Time-to-response (TTR)
Duration from visit 1 to good asthma control (C-ACT\>19)
Time frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Time-to-loss-of-control (TTLOC)
Duration from the visit 2 and 3 until loss of asthma control (C-ACT\<16) or asthma exacerbation
Time frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Lung function
Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method
Time frame: Every visit up to maximum 6 months
Ran from Nov 2017 to primary completion in Nov 2019, 23 months.
Of 38 observational studies under Respiratory Sounds, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 97. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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HUS Skin and Allergy Hospital