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Идёт набор NCT07341776

Steroid Use in Treatment of Allergic Reactions to Food

Фаза IV С лечением Anaphylactic Reaction Anaphylaxis Allergy in Children IgE Mediated Food Allergy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Antihistamines, Systemic corticosteroids, Adrenaline (rescue medication).
Кому может быть актуально
Состояния в реестре: Anaphylactic Reaction, Anaphylaxis, Allergy in Children, IgE Mediated Food Allergy. Базовые параметры: 6 мес. — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
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Официальное название

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.

Обзор

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.

Вмешательства

  • Препарат Antihistamines
    Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.
  • Препарат Systemic corticosteroids
    Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.
  • Препарат Adrenaline (rescue medication)
    Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.

Первичные конечные точки

  • Time to complete resolution of allergic symptoms [Срок оценки: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.]
Вторичные конечные точки (6)
  • Total number of adrenaline doses and cumulative adrenaline dose [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From onset of allergic symptoms during the oral food challenge until patient discharge, assessed up to 24 hours.]
  • Late-phase allergic reactions [Срок оценки: From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.]

Критерии участия

Критерии включения

  • suspected or confirmed IgE-mediated food allergy

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Швейцария · 2 центра
  • University Children's Hospital Basel — Basel
  • University Children's Hospital, Zürich — Zurich

Идентификаторы

NCT: NCT07341776 · BASEC-2025-00320 · HumRes67580 · SNCTP000006696

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗