Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea

NCT06917768 | Completed

• 1 other identifier: Tfem/2023/50
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obstructive Sleep Apnea

Keywords

Corticosteroids; Tonsillar hypertrophy; Pediatric OSA; Surgery; Coblation

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children.

  In Group 2, failure of medical treatment is defined by a persistence of apnea assessed by the clinician and parents and therefore a need for surgery within 6 months of follow-up, while therapeutic success reflects an improvement in symptoms and a disappearance of apnea documented by video, and therefore the absence of need for surgery after 6 months of follow-up.

  6 months

Secondary Outcomes (3)

• Evaluate the evolution of symptoms' severity

  6 months

• Evaluate tonsils' size evolution with treatment

  6 months

• Evaluate potential treatment-related side effects

  6 months

Study Arms (2)

Patients undergoing surgical treatment (adenotonsillectomy).

ACTIVE COMPARATOR

Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.

Procedure: Adenotonsillectomy

Patients undergoing medical treatment (short-term and low dose oral corticosteroids).

EXPERIMENTAL

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.

Drug: Prednisolone

Interventions

Adenotonsillectomy PROCEDURE

Children undergoing adenoidectomy and intracapsular tonsillectomy using Coblation™, by the same surgeon at HDF.

Also known as: Coblation

Patients undergoing surgical treatment (adenotonsillectomy).

Prednisolone DRUG

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.

Patients undergoing medical treatment (short-term and low dose oral corticosteroids).

Eligibility Criteria

• Age: 18 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hotel Dieu de France Hospital: lead

Study Sites (1)

Hotel Dieu de France

Beirut, Lebanon

Location

Related Publications (3)

• 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.

  PMID: 31375615 BACKGROUND

• 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.

  PMID: 16735907 BACKGROUND

• 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.

  PMID: 17118282 BACKGROUND

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Simon J Rassi, Medical Doctor

  Hotel Dieu de France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It is an interventional, prospective, non randomized controlled trial.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: December 9, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

LE (1)