Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wheezing bronchitis diagnosed by a physician
- •Need for salbutamol treatment at the emergency department
- •Positive nasopharyngeal rhinovirus or picornavirus finding in point-of-care testing
排除标准
- •Need for immediate resuscitation
- •Immediate transfer to ICU
- •Suspected pneumonia based on the auscultation finding
- •Suspected serious bacterial infection
- •Other respiratory virus finding in the absence of rhinovirus or picornavirus
- •Positive respiratory syncytial virus finding
- •Positive SARS-coronavirus-2 finding
- •Positive Mycoplasma pneumoniae finding
- •Positive Bordetella pertussis finding
- •Contact with a person with chickenpox within 14 days
- •Active chickenpox
- •Suspected foreign body of the respiratory tract
- •Immunosuppressive treatment
- •Systemic corticosteroid treatment within 14 days
- •Allergy to corticosteroids
研究组 & 干预措施
Prednisolone
Prednisolone Sodium Phosphate (25 mg/5 mL) oral suspension administered 1 mg/kg* (up to 20 mg = 4 mL) once a day for 3 days.
*(0-5 kg: 5 mg; 5.01-7.5 kg: 7.5 mg; 7.51-10 kg: 10 mg; 10.01-12.5 kg: 12.5 mg; 12.51-15 kg: 15 mg; 15.01-17.5 kg: 17.5 mg; ≥ 17.51 kg: 20 mg)
干预措施: Prednisolone Sodium Phosphate (Drug)
Placebo
Sugar syrup oral suspension containing saccharum 630-640 mg/g and aqua purificata 360-370 mg/g administered the same amount in milliliters as experimental product (up to 4 mL) once a day for 3 days.
干预措施: Sugar syrup (Drug)
结局指标
主要结局
Length of hospital stay
时间窗: Within 7 days of study entry
The difference (in minutes) between the study entry and the time that the patient is deemed to be fit for discharge (sign off for discharge) Subgroup analyses for the primary outcome are performed in following subgroups: * Children presenting with first episode of wheezing * Children with at least one previous episode of wheezing diagnosed by a physician * Children with a cycle threshold number of \< 30 for detected picornavirus * Children with a cycle threshold number of 30-37 for detected picornavirus * Children with a cycle threshold number of 38-40 for detected picornavirus
次要结局
- Proportion of patients with cough at 14 days of study entry(At 14 days of study entry)
- Duration of respiratory distress(Within 14 days of study entry)
- Recurrence of wheezing (time)(Within 12 months of study entry)
- Total length of hospital stay(Within 7 days of study entry)
- Intensive care unit (ICU) admissions(Within 7 days of study entry)
- Supplemental oxygen(Within 7 days of study entry)
- Pediatric Early Warning Signs (PEWS) score(Within 7 days of study entry)
- Hospital re-admission(Within 14 days of study entry)
- Deaths(Within 30 of study entry)
- Recurrence of wheezing (proportion)(Within 12 months of study entry)
- Daily administrated asthma medication(Within 24 months of study entry)
- Recurrence of wheezing(Within 56 days of study entry)
- Duration of cough(Within 14 days of study entry)
- Duration of salbutamol use(Within 14 days of study entry)
- Antibiotics and asthma medications(Within 24 months of study entry)
研究者
Terhi Tapiainen
Professor of Pediatrics, Head of Pediatric Infectious Diseases and Emergency Department
University of Oulu