Anaphylactic Reaction, Anaphylaxis, Allergy in Children, IgE Mediated Food Allergy
Conditions
Brief summary
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.
Interventions
DRUGAntihistamines
Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.
Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.
DRUGAdrenaline (rescue medication)
Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.
Sponsors
Johannes Trueck
University Children's Hospital Basel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* suspected or confirmed IgE-mediated food allergy
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete resolution of allergic symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 intramuscular adrenaline administrations and cumulative adrenaline dose administered per participant for treatment of allergic reactions during the oral food challenge. |
| 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. | Total number of oral antihistamine administrations and cumulative antihistamine dose administered per participant for treatment of allergic reactions during the oral food challenge. |
| 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. | Severity of allergic reactions assessed using PRACTALL consensus definitions and documented on a standardized monitoring form during the oral food challenge. |
| 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. | Occurrence of hospitalization or admission to an intensive care unit (ICU) for management of allergic reactions occurring during the oral food challenge. |
| 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. | Time from onset of allergic symptoms leading to discontinuation of the oral food challenge until discharge from hospital or outpatient unit. |
| Late-phase allergic reactions | From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction. | Occurrence of late-phase allergic reactions, defined as recurrence or worsening of allergic symptoms after complete resolution of the initial reaction, without further allergen exposure, following treatment during the oral food challenge. |
Countries
Switzerland
Contacts
CONTACTJohannes Trück, PD Dr. med. DPhil
Outcome results
None listed