Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Asthma Outcomes in Children After Adenotonsillectomy

13. februar 2019 opdateret af: Diana Shafeek Ibrahiem Ghali, Assiut University

The Effect of Adenotonsillectomy on Asthma Control in Preschool Children With Obstructive Sleep Apnea

The aim of the study is to assess the effect of adenotonsillectomy on level of asthma control in preschool children with obstructive sleep apnea.

Studieoversigt

Status

Ukendt

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

Observationel

Tilmelding (Forventet)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 5 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

study will be carried out on pre school children with bronchial asthma undergoing adenoidectomy or adenotonsilectomy for obstructive sleep apnea. The study will be conducted in otolaryngology department, Assiut university hospital. The study will be carried on 60 consecutive cases.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Diana shafeek Ibrahiem Ghali, Resident, Assiut University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. april 2019

Primær færdiggørelse (Forventet)

1. april 2021

Studieafslutning (Forventet)

1. juni 2021

Datoer for studieregistrering

Først indsendt

7. februar 2019

Først indsendt, der opfyldte QC-kriterier

13. februar 2019

Først opslået (Faktiske)

15. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Obstruktiv søvnapnø

3
Abonner