A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Fever >=38C Within 32 Hours of Vaccination.
研究概览
简要总结
The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.
详细描述
Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. This randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is a current Group Health enrollee.
- •Child will be seen at a Group Health clinic for a Well Child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age.
排除标准
- •If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
- •If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.
研究组 & 干预措施
Acetaminophen
Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
干预措施: Acetaminophen (Drug)
Placebo
Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
干预措施: placebo (Other)
结局指标
主要结局
Fever >=38C Within 32 Hours of Vaccination.
时间窗: Fever within 32 hours following vaccination
Fever, defined as rectal temperature \>=38C within 32 hours of vaccination.
次要结局
- Infant Time Lost From Sleep(On the night following vaccinations)
- Parent Time Lost From Sleep(On the night following vaccinations)
- Study Assignment Unblinded(At any time during participation in the study)
- Infant Fussiness(Within 32 hours of vaccination)
- Fever >=39C Within 32 Hours of Vaccination.(Fever within 32 hours following vaccination)
- Medical Utilization(Within 32 hours of vaccination.)
- Parent Time Lost From Work(Through the day after vaccination)