ACTRN12615000563561招募中3 期
A multi-centre randomised controlled trial of children aged between 6 months and 18 years presenting to emergency departments with symptoms of Bell's palsy, to determine whether treatment with oral prednisolone versus a placebo, increases the proportion of children who have complete recovery at 1 month, where complete recovery is defined as grade 1 on the House Brackmann scale.
Franz Babl0 个研究点目标入组 540 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 540
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 6 Months 至 18 Years（—）
- 性别
- All
入选标准
- •Patients must be aged between 6 months to less than 18 years, weigh greater than or equal to 5kg, be diagnosed with Bell's Palsy by their treating doctor and have an acute onset of symptoms of Bell's palsy for less than 72 hours prior to randomisation
排除标准
- •- Previous episode of Bell's Palsy or previously randomised in BellPIC study
- •- Contraindication to prednisolone: active or latent tuberculosis, systemic fungal infection, known hypersensitivity to prednisolone, diminished cardiac function, diabetes mellitus, peptic ulcer or chronic renal function, multiple sclerosis or recent active herpes zoster or chickenpox
- •- current use of systemic or inhaled steroid, or use within 2 weeks prior to the onset symptoms
- •- current or past oncological diagnosis
- •- FBE result (if obtained during this illness) may indicate leukaemia
- •- Pregnancy and/or lactating
- •- Currently receiving medications for which prednisolone is contraindicated
- •- Immunisation with a live vaccine within the previous 1 month
- •- Requirement for live vaccine within 6 weeks of first dose of prednisolone
- •- Signs of upper motor neuron VII nerve palsy (weakness of lower half of the face only)
- •- Current or recent (1 week prior to Bell's palsy symptoms) otitis media
- •- Evidence of vesicles on the ear from or vesicles/ulcers elsewhere on the body suggestive of recent herpes simplex, herpes zoster or chickenpox
- •- Known significant facial trauma within 1 week prior to symptoms appearing
- •- Referred to GP clinic in Emergency Department or failed to wait
- •- Unable to attend a follow up visit in one month time
- •- Any other condition at risk of being influenced by study treatment or completion of study
- •- Parents will not be able to comply with the study, or have enough understanding of the study.
研究者
相似试验
进行中（未招募）
3 期
Trial of sertraline to prevent post-traumatic brain injury depressioDepressive disorder after traumatic brain injuryMental and Behavioural DisordersISRCTN17518945King's College Hospital514
已完成
不适用
Internet-based relapse prevention for in-patients with anorexia nervosaSevere anorexia nervosa (AN)Mental and Behavioural DisordersEating disordersISRCTN18274621South London and Maudsley NHS Foundation Trust (UK)98
招募中
3 期
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled TrialACTRN12608000053325Australian and New Zealand Intensive Care Research Centre1,600
已完成
不适用
The clinical and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shockSevere sepsis/septic shockInfections and InfestationsOther septicaemiaISRCTN36307479Intensive Care National Audit and Research Centre (ICNARC) (UK)1,260
已完成
不适用
Xience® or Vision® stent - Management of Angina in the elderlyCoronary diseaseacute coronary syndromesCirculatory SystemOther acute ischaemic heart diseasesISRCTN92243650Brighton and Sussex University Hospitals NHS Trust (UK)800