NCT06917768

Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea

Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea, a Non-Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Hotel Dieu de France Hospital · Academic / Other
• Sex: All
• Age: 18 Months – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Obstructive Sleep Apnea

Interventions

Type	Name	Description
PROCEDURE	Adenotonsillectomy	Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.
DRUG	Prednisolone	The second Group includes children whose parents have refused surgery despite informed understanding of the therapeutic algorithm of OSA. They received medical treatment consisting of a 1-month treatment with intranasal corticosteroids, coupled with a 5-day course of oral corticosteroids (prednisolone) at a safe dose of 1mg/kg.

Timeline

• Start date: 2022-12-09
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2025-04-08
• Last updated: 2025-04-17

Locations

1 site across 1 country: Lebanon