- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03842618
Asthma Outcomes in Children After Adenotonsillectomy
The Effect of Adenotonsillectomy on Asthma Control in Preschool Children With Obstructive Sleep Apnea
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Asthma is the most common chronic disease in children ,in children younger than six years it is difficult to diagnose asthma as pulmonary function tests can not be performed reliably before the age six .
Wheezing is one of the main symptoms of asthma. Young children with multiple trigger wheeze as activities ,laughing and crying are more likely to have asthma compared with episodic (viral) wheeze.
The mainstay of asthma control is daily administration of inhaled corticosteroids, long acting beta2 agonists and avoid exposure of asthma triggers as seasonal allergens and environmental pollution particularly tobacco smoke exposure.
Recent studies have found asthma to be associated with overlapping comorbidities including gastroesophageal reflux,obesity and obstructive sleep apnea.This studies have introduced therapeutic strategies aimed at improving asthma control by management of these coexisting conditions.
Pathophysiological feature of childhood obstructive sleep apnea is presence of increased airway inflammation promoting of hypertrophy of upper airway adenotonsillar tissues .
The latter promotes increased pharyngeal resistance thus predispose the upper airway to episodically collapse and cause fragmented sleep that characterize obstructive sleep apnea.
Surgically adenotonsillectomy is the first line of therapy in childhood obstructive sleep apnea and has favorable outcomes ,including improvements of respiratory sleep disturbances and in reducing markers of asthma and reduction in the use of asthma therapies.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- preschool children (2_5)years with criteria of bronchial asthma with obstructive sleep apnea regardless sex.
Exclusion Criteria:
- patients with other disorders that may cause obstructive sleep apnea as cranio facial syndrome , Down syndrome, cerebral palsy ,obesity,sickle cell disease, low birth weight.
- Any associated medical comorbidity that contraindicates general anesthesia.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
preschool children who suffer from bronchial asthma will be assessed by questionnaire based history to assess level of asthma control as stated in GINA 2018 before and after adenotonsillectomy.
Tidsramme: up to 1year
|
Questionnaire based history will be obtained from the parents of children before adenotonsillectomy to assess level of asthma control in preschool children as stated in Global Initiative for Asthma (GINA 2018); ask parents in the past 4 weeks, has child had A-Day time asthma symptoms for more than a few minutes, more than once a week? B-Any activity limitation due to asthma? (Runs, tires easily, playing?) C-Reliever medication needed more than once a week? D-Any night waking or night coughing due to asthma? The child will be well controlled if none of this question were answered by yes. The child will be partially controlled if 1-2 of this question were answered by yes. The child will be un controlled if 3-4 of these questions were answered by yes. Repeat this questions after adenotonsillectomy to show prognosis of asthma after surgery. |
up to 1year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Diana shafeek Ibrahiem Ghali, Resident, Assiut University
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AOICAA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Kliniske forsøg med Obstruktiv søvnapnø
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Aventure ABAktiv, ikke rekrutterende
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The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
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Northwell HealthJazz PharmaceuticalsRekrutteringElektrisk status Epilepticus af Slow-Wave SleepForenede Stater
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University of Geneva, SwitzerlandAfsluttetNatlige benkramper | Sleep Wake Transition DisordersSchweiz
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Tyco Healthcare GroupUkendt
-
Maastricht University Medical CenterEpilepsiecentrum KempenhaegheAfsluttetRolandsk Epilepsi | Landau-Kleffners syndrom | Natlig frontallappens epilepsi | Elektrisk status Epilepticus under Slow Wave SleepHolland