Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-09

Study Completion Date

2023-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Obstructive Sleep Apnea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

It is an interventional, prospective, non randomized controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients undergoing surgical treatment (adenotonsillectomy).

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

Group Type ACTIVE_COMPARATOR

Adenotonsillectomy

Intervention Type PROCEDURE

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

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

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.

Group Type EXPERIMENTAL

Prednisolone

Intervention Type 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.

Interventions

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Adenotonsillectomy

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

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Other Intervention Names

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Coblation

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No