Clinical trial NCT06917768: Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea
Official title: Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea, a Non-Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obstructive Sleep Apnea
Keywords: Corticosteroids
Tonsillar hypertrophy
Pediatric OSA
Surgery
Coblation
Lead sponsor: Hotel Dieu de France Hospital
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is an interventional, prospective, non randomized controlled trial.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* All children aged between 18 months and 8 years diagnosed with OSAS secondary to adenotonsillar hypertrophy

Exclusion Criteria:

* Children under 18 months or over 8 years old
* History of acute or chronic cardiorespiratory neuromuscular, or metabolic diseases
* Congenital craniofacial anomalies
* Chromosomal disorders
* Epilepsy

Primary outcomes:
measure: Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children.
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate the evolution of symptoms' severity
timeFrame: 6 months
measure: Evaluate tonsils' size evolution with treatment
timeFrame: 6 months
measure: Evaluate potential treatment-related side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
Study officials:
affiliation: Hotel Dieu de France
name: Simon J Rassi, Medical Doctor
role: STUDY_DIRECTOR
References:
citation: Fernandes RM, Wingert A, Vandermeer B, Featherstone R, Ali S, Plint AC, Stang AS, Rowe BH, Johnson DW, Allain D, Klassen TP, Hartling L. Safety of corticosteroids in young children with acute respiratory conditions: a systematic review and meta-analysis. BMJ Open. 2019 Aug 1;9(8):e028511. doi: 10.1136/bmjopen-2018-028511.
citation: Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.
citation: Meltzer LJ, Mindell JA. Sleep and sleep disorders in children and adolescents. Psychiatr Clin North Am. 2006 Dec;29(4):1059-76; abstract x. doi: 10.1016/j.psc.2006.08.004.