drugset / Trial / NCT06917768

Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea

NCT06917768

Completed 87 enrolled Hotel Dieu de France Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This prospective interventional clinical trial (non-randomized) aims to evaluate oral corticosteroids' role as an alternative to surgery (gold-standard) in the treatment of obstructive sleep apnea in children. It also evaluates the evolution of symptoms' severity as well as any side effects linked to treatment. This prospective study included children aged between 18 months and 8 years who consulted the same pediatric ENT physician's clinic for OSA secondary to adenotonsillar hypertrophy with no other comorbidities. They were divided into 2 Groups. Children undergoing intracapsular adenotonsillectomy by Coblation™ (Group 1) were compared to those receiving oral prednisolone at a dose of 1mg/kg for 5 days and 1 month of intranasal corticosteroids (Group 2). The follow-up tools were the Pediatric Sleep Questionnaire (PSQ) score and the size of the tonsils (Brodsky classification) evaluated at 1, 3 and 6 months.

Timeline

Start
2022-12-09
Primary completion
2023-12-15
Completion
2023-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified 1 mg/kg Oral