Allergen Provocations- HCA Children's Hospital

Allergen Provocations at Hans Christian Andersen Children's Hospital

A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.

Study Overview

• Status: Recruiting
• Conditions: Allergy in Children
• Intervention / Treatment: Diagnostic test: Oral provocation test

Detailed Description

The purpose of the study is to investigate the impact of co-morbidities, history, and allergen tests on the outcome of allergen provocation tests.

Subjects are children aged 0-18 years old investigated for allergy to foods or antibiotics. Data entered in the database are demographics, co-morbidities, symptoms, SPT, specific IgE and details of the allergen provocations.

• Study Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Josefine Gradman, phd; Phone Number: +4529241375; Email: josefine.gradman@rsyd.dk
• Study Contact Backup: Name: Susanne Halken, DMSc; Email: susanne.halken@rsyd.dk

Study Locations

• Denmark
  • Odense C
    • Odense, Odense C, Denmark, 5000
      • Recruiting
      • Hans Christian Andersen Children's Hospital
      • Contact: Josefine Gradman; Phone Number: 004529241375; Email: j.gradman@dadlnet.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children referred to the department of pediatrics for investigation of allergy to foods or antibiotics

Description

Inclusion Criteria:

clinical suspicion of allergy to foods or antibiotics informed concent -

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

15

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Antibiotics; Children aged 0-18 years investigated for allergy to antibiotics	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Milk; Children aged 0-18 years investigated for allergy to milk	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Egg; Children aged 0-18 years investigated for allergy to egg	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Peanut; Children aged 0-18 years investigated for allergy to peanut	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Hazelnut; Children aged 0-18 years investigated for allergy to hazelnut	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Sesame; Children aged 0-18 years investigated for allergy to sesame	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Wheat; Children aged 0-18 years investigated for allergy to wheat	Diagnostic test: Oral provocation test; Titrated provocation with allergen
walnut; Children aged 0-18 years investigated for allergy to walnut	Diagnostic test: Oral provocation test; Titrated provocation with allergen
cashew; Children aged 0-18 years investigated for allergy to cashew	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Pistachio; Children aged 0-18 years investigated for allergy to pistachio	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Almond; Children aged 0-18 years investigated for allergy to almond	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Soy; Children aged 0-18 years investigated for allergy to soy	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Fish; Children aged 0-18 years investigated for allergy to fish	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Shellfish; Children aged 0-18 years investigated for allergy to shellfish	Diagnostic test: Oral provocation test; Titrated provocation with allergen
Poppy seed; Children aged 0-18 years investigated for allergy to poppy seed	Diagnostic test: Oral provocation test; Titrated provocation with allergen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The association of allergy tests with the result of allergen provocation	The value of specific IgE and SPT to predict the outcome of a allergen provocation	5 years

Collaborators and Investigators

• Sponsor: Josefine Gradman

Publications and helpful links

General Publications

• Gradman J, Petersen BT, Halken S. Oral food challenge with raw egg: Sixty-minute- compared with 30-minute dosing interval. Clin Exp Allergy. 2022 Sep;52(9):1114-1117. doi: 10.1111/cea.14187. Epub 2022 Jul 4. No abstract available.
• Petersen BT, Gradman J. Prospective study of 5-day challenge with penicillins in children. BMJ Paediatr Open. 2020 Aug 4;4(1):e000734. doi: 10.1136/bmjpo-2020-000734. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): October 1, 2038
• Study Completion (Estimated): October 1, 2039

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HCA-AP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No