Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis

Официальное название

Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis: the VISION Pilot Randomized Clinical Trial

Обзор

The goal of this pilot randomized controlled trial is to understand whether we can successfully conduct a larger definitive clinical trial in the future. The current pilot study will test various aspects of the larger trial and help us improve its design if needed. The investigators are mainly interested in knowing whether they can (1) recruit enough patients, (2) administer the intervention, and (3) collect all the data needed from patients. The definitive randomized controlled trial will assess if dexamethasone is superior to placebo for treating children and youth hospitalized with orbital cellulitis.

Подробное описание

This is a double-blinded, placebo-controlled, internal pilot randomized controlled trial, with two parallel groups with a 1:1 allocation ratio, at The Hospital for Sick Children (Toronto, ON) and Stollery Children's Hospital (Edmonton, AB).The purpose of the study is to determine the feasibility of a definitive randomized controlled trial, which will determine whether IV dexamethasone 0.3 mg/kg after randomization and 24 hours later (2 doses total) is superior to placebo for children and youth hospitalized with orbital cellulitis.

Children and youth (n=30) hospitalized with orbital cellulitis will be randomized to receive IV dexamethasone 0.3 mg/kg (first dose after randomization, second dose 24 hours later) or placebo. The primary feasibility outcome of this pilot trial is recruitment rate. Secondary feasibility outcomes include (a) intervention fidelity, (b) completion of definitive trial primary, and (c) completion of definitive trial secondary outcomes.

Вмешательства

• Препарат Dexamethasone 0.3mg/kg
  SANDOZ-DEXAMETHASONE SODIUM PHOSPHATE INJ USP 4MG/ML (5 mL vial) (DIN# 00664227) or any brand available commercially in the Canadian market. Dexamethasone 0.3 mg/kg (max dose 12 mg) will be given by IV after randomization. The second dose will be given 24 hours (+/-8 hours) after the first dose. The most recent weight recorded in the patient's chart will be used for the dose calculation.
• Препарат Placebo Control
  Sodium Chloride 0.9% Injection USP Placebo Baxter brand (or any commercially available in the Canadian market) given by IV, first dose administered after randomization and second dose 24 hours (+/- 8 hours) after the first.

Первичные конечные точки

• Recruitment rate [Срок оценки: From start of recruitment to end of recruitment (anticipated 18 months).]

Вторичные конечные точки (2)

• Intervention fidelity [Срок оценки: 96 hours after the patient is admitted to hospital.]
• Completion of definitive trial primary and secondary outcomes [Срок оценки: Three months after the patient is discharged from hospital.]

Критерии участия

Критерии включения

• Age 2.00 months -17.99 years (prior to 18th birthday)
• Confirmed or suspected diagnosis of orbital cellulitis as determined by the attending physician, medical team, and/or delegate's clinical judgement, based on one or more features of orbital cellulitis (i.e., ophthalmoplegia, pain and/or limitation with extraocular movements, chemosis, blurred vision, eye swollen shut, and/or proptosis).
• Scheduled to be admitted or admitted to hospital for less than 36 hours.
• Informed consent provided in accordance with institutional policies

Критерии исключения

• Transferred directly from outside hospital inpatient setting to a participating hospital site's inpatient setting with over 36 hours having passed since admission to outside hospital. If within 36 hours, patient is eligible.
• Treatment with IV or PO systemic corticosteroids within 1 week of presentation
• Recent hospital admission for orbital cellulitis within 1 week of presentation
• Current systemic fungal infection
• Contraindication for dexamethasone or components of dexamethasone IV formulation
• Clinically relevant varicella exposure in the previous 21 days
• Previous enrollment in this study
• No telephone/mobile/email
• Poor mastery of English, or medical interpreter not available for languages other than English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• The Hospital for Sick Children — Toronto
• Stollery Children's Hospital — Edmonton

Публикации

• Gonsalves CL, Borkhoff C, Mahant S, Drouin O, Pound C, Quet J, Wahi G, Bayliss A, Vomiero G, Foulds JL, Kanani R, Sakran M, Sehgal A, Pullenayegum E, Widjaja E, Reginald A, Wolter NE, Parkin PC, Gill PJ; Periorbital and Orbital Cellulitis (POC) Multicentre Study Group and Canadian Paediatric Inpatient Research Network (PIRN). Association of systemic corticosteroids and clinical outcomes in childre PMID 41381246
• Kornelsen E, Mahant S, Parkin P, Ren LY, Reginald YA, Shah SS, Gill PJ. Corticosteroids for periorbital and orbital cellulitis. Cochrane Database Syst Rev. 2021 Apr 28;4(4):CD013535. doi: 10.1002/14651858.CD013535.pub2. PMID 33908631
• Gill PJ, Mahant S, Hall M, Parkin PC, Shah SS, Wolter NE, Mestre M, Markham JL. Association Between Corticosteroids and Outcomes in Children Hospitalized With Orbital Cellulitis. Hosp Pediatr. 2022 Jan 1;12(1):70-89. doi: 10.1542/hpeds.2021-005910. PMID 34877598

Идентификаторы

NCT: NCT07345819 · 3800

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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