Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea

Hotel Dieu de France Hospital

Status: Completed

Conditions: Pediatric Obstructive Sleep Apnea

Treatments: Drug: Prednisolone; Procedure: Adenotonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06917768

Tfem/2023/50

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 months to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Patients undergoing surgical treatment (adenotonsillectomy).

Active Comparator group

Description:

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

Treatment:

Procedure: Adenotonsillectomy

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

Experimental group

Description:

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.

Treatment:

Drug: Prednisolone