Asthma Outcomes in Children After Adenotonsillectomy

NCT ID: NCT03842618

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-06-01

Brief Summary

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

Detailed Description

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Diana Shafeek Ibrahiem Ghali

the principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana shafeek Ibrahiem Ghali, Resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Ali Ragaei Abd El-Hakim, prof.dr.

Role: CONTACT

alyragie@aun.edu.eg

01115444779

Mohamed Ahmed Abdalhay Alhussaini, lecturer

Role: CONTACT

mohamed-alhussaini@aun.edu.eg

01067485885

Other Identifiers

AOICAA

Identifier Type: -

Identifier Source: org_study_id