Asthma Outcomes in Children After Adenotonsillectomy

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03842618
• Other study ID #: AOICAA
• Status: Not yet recruiting
• Start date: April 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: Ali Ragaei Abd El-Hakim, prof.dr.
• Phone: 01115444779
• Email: alyragie[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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