Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis: the VISION Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Dexamethasone 0.3 mg/kg (max dose 12 mg) IV after randomization, and a second dose 24 hours (+/-8 hours) after the first dose
干预措施: Dexamethasone 0.3mg/kg (Drug)
Placebo
Sodium Chloride 0.9% IV after randomization and second dose 24 hours (+/- 8 hours) after the first dose
干预措施: Placebo Control (Drug)
结局指标
主要结局
Recruitment rate
时间窗: From start of recruitment to end of recruitment (anticipated 18 months).
Recruitment rate is measured as the number of patients agreeing to participate in the trial and are randomized, divided by the number of patients screened as eligible at 18 months after initiation of the trial recruitment (per site).
次要结局
- Intervention fidelity(96 hours after the patient is admitted to hospital.)
- Completion of definitive trial primary and secondary outcomes(Three months after the patient is discharged from hospital.)
研究者
Peter Gill
Staff Paediatrician and Senior Scientist
The Hospital for Sick Children