Clinical trial NCT03842618: Asthma Outcomes in Children After Adenotonsillectomy
Official title: The Effect of Adenotonsillectomy on Asthma Control in Preschool Children With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: asthma- obstructive sleep apnea-adenotonsillectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: up to 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Diana shafeek Ibrahiem Ghali, Resident
role: PRINCIPAL_INVESTIGATOR
References: