Evaluation of Emergency Medication in Children With Food Allergies: a Prospective, Randomized Clinical Multicenter Study Comparing Antihistamines Versus Antihistamines Plus Steroids in a Controlled Setting of Oral Food Challenges in Children.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Time to complete resolution of allergic symptoms
研究概览
简要总结
In this study, the investigators want to find out whether a specific medication commonly used for severe allergic reactions is really necessary. When children have allergic reactions to foods, they are often given medications to relieve the symptoms. In addition to adrenaline and antihistamines, steroids are frequently administered in German-speaking Switzerland. However, it is unclear whether steroids are really helpful in this situation. To investigate this, the investigators are comparing two groups: one group receives additional steroids, and the other does not. Which treatment a participant receives is decided randomly, like flipping a coin. The study takes place during a pre-scheduled provocation test at the clinic. If an allergic reaction occurs, the usual emergency medications will be administered. Doctors will closely monitor how the reaction develops. No additional tests or visits are required. The results of this study could help improve allergy treatment in the future.
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
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or confirmed IgE-mediated food allergy
排除标准
- •Non-IgE mediated food allergies
- •Non-food allergies
- •Age outside the specified range
- •Contraindications for an oral food challenge or oral steroid use within one week before the challenge.
研究组 & 干预措施
Antihistamines plus oral steroids
Participants receive oral antihistamines plus oral systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated.
干预措施: Antihistamines (Drug)
Antihistamines plus oral steroids
Participants receive oral antihistamines plus oral systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated.
干预措施: Systemic corticosteroids (Drug)
Antihistamines plus oral steroids
Participants receive oral antihistamines plus oral systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated.
干预措施: Adrenaline (rescue medication) (Drug)
Antihistamines only (no steroids)
Participants receive oral antihistamines without systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated.
干预措施: Antihistamines (Drug)
Antihistamines only (no steroids)
Participants receive oral antihistamines without systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated.
干预措施: Adrenaline (rescue medication) (Drug)
结局指标
主要结局
Time to complete resolution of allergic symptoms
时间窗: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.
Time from onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, comparing treatment with antihistamines alone versus antihistamines plus oral steroids.
次要结局
- Total number of adrenaline doses and cumulative adrenaline dose(From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.)
- Total number of antihistamine doses and cumulative antihistamine dose(From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.)
- Severity of allergic reaction(From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.)
- Hospitalization and intensive care unit admission(From onset of allergic reaction during the oral food challenge until hospital discharge or end of observation period, assessed up to 24 hours.)
- Time from onset of allergic symptoms to patient discharge(From onset of allergic symptoms during the oral food challenge until patient discharge, assessed up to 24 hours.)
- Late-phase allergic reactions(From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.)
研究者
Johannes Trueck
Head, Division of Allergy
University Children's Hospital, Zurich