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The muscle activity of the diaphragm and intercostal muscles before and after treatment with Salbutamol


- candidate number16345
- NTR NumberNTR4565
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-feb-2014
- Secondary IDsMETc2013/369 Medisch Etische toetsingscommissie UMC Groningen
- Public TitleThe muscle activity of the diaphragm and intercostal muscles before and after treatment with Salbutamol
- Scientific TitleThe muscle activity of the diaphragm and intercostal muscles in wheezy children during hospitalization, before and after treatment with salbutamol
- ACRONYM
- hypothesisThe tone of the intercostal muscles and the diaphragm is, in wheezy children, higher before treatment with Salbutamol than after treatment
- Healt Condition(s) or Problem(s) studiedAcute asthma, Dyspnea , Children
- Inclusion criteria-Children between 3 months and 6 year old.
-Hospitalized at the Universitair Medisch Centrum Groningen because of dyspnea
-Treated with Salbutamol
- Exclusion criteria-Congenital disorders which cause dyspnea like Congenital heart defects or Cystic Fibrosis.
- Status after Hernia diaphragmatica
- Children with an allergy to EMG patches
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 11-feb-2014
- planned closingdate
- Target number of participants35
- InterventionsBecause this is an observational study there will be no interventions.The measurements start at first presentation at hospital. One measurement consists of 3 parts: EMG, Clinical Asthma Score and the Borg-Scale, measured by parents. The measurement starts before treatment with Salbutamol. 15 Minutes after treatment the measurement will be repeated.
- Primary outcomeEMG measurements
- Secondary outcomeClinical Asthma Score
Borg scale
- TimepointsThe first measurement starts before the first treatment with Salbutamol.
The measurements will be repeated twice a day during the first three days of hospitalization. At the day of dismissal the measurements will be repeated for the last time. These will be used as control measurement.
When a child is able to go home within three days of hospitalization, the remaining measurements will be canceled and the last measurement will be seen as the measurement for dismissal.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. E.J.L.E. Vrijlandt
- CONTACT for SCIENTIFIC QUERIESDr. E.J.L.E. Vrijlandt
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryOur aim is to study the tone of the intercostal muscles and the diaphragm in wheezy children, before treatment with Salbutamol and after treatment.
- Main changes (audit trail)
- RECORD4-feb-2014 - 1-jun-2014


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