Observation Periods and Biphasic Reaction Risk Factors in Pediatric Emergency Anaphylaxis Cases

NCT07231393 | Completed

• 1 other identifier: ADUPEDANAPH
• Study Type: observational
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study reviews the medical records of children who presented to the pediatric emergency department of Adnan Menderes University Hospital with a diagnosis of anaphylaxis between January 2014 and December 2024. The aim is to determine how long children were observed in the emergency department, how often biphasic reactions (a second wave of symptoms) occurred, and which risk factors (such as delayed adrenaline use or asthma) may increase this risk. The results will help improve the care of children with anaphylaxis and guide recommendations for safe observation times.

Conditions

Child; Anaphylaxis; Pediatric Emergency Care; Biphasic Anaphylactic Reaction

Outcome Measures

Primary Outcomes (1)

• Incidence of Biphasic Reactions

  he proportion of pediatric patients who developed a biphasic reaction, defined as recurrence of anaphylaxis symptoms after complete resolution of the initial episode, within 1-72 hours.

  Within 72 hours of the initial anaphylaxis episode

Secondary Outcomes (2)

• Mean Observation Period in the Pediatric Emergency Department

  During index visit (hours)

• Risk Factors Associated with Biphasic Reactions

  During index visit and follow-up within 72 hours

Study Arms (1)

Pediatric Anaphylaxis Cohort

Children under 18 years of age who presented to the Pediatric Emergency Department of Adnan Menderes University Hospital between January 2014 and December 2024 with a diagnosis of anaphylaxis, defined according to WAO 2020 criteria. All patients meeting eligibility criteria were included retrospectively from medical records.

Eligibility Criteria

• Age: 0 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents (\<18 years) who presented to the Pediatric Emergency Department of Adnan Menderes University Hospital between January 1, 2014, and December 31, 2024, with a diagnosis of anaphylaxis.

You may qualify if:

• Age \<18 years
• Diagnosis of anaphylaxis according to World Allergy Organization (WAO) 2020 criteria
• Complete clinical data available in medical records

You may not qualify if:

• Incomplete or missing clinical data
• Cases not meeting WAO 2020 anaphylaxis definition
• Patients presenting with isolated urticaria or localized allergic reactions only

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Related Publications (4)

• Soyak Aytekin E, Sirin S, Kiratli Nalbant E, Ata N, Sertcelik A, Ulgu MM, Birinci S, Harmanci K, Akelma Z. Changes in anaphylaxis trends and characteristics in emergency department admissions in Turkiye: From 2015 to 2021 based on the Ministry of Health database. World Allergy Organ J. 2024 Dec 24;18(1):101019. doi: 10.1016/j.waojou.2024.101019. eCollection 2025 Jan.

  PMID: 39810830 BACKGROUND

• Gaspar A, Santos N, Faria E, Pereira AM, Gomes E, Camara R, Rodrigues-Alves R, Borrego LM, Carrapatoso I, Carneiro-Leao L, Morais-Almeida M, Delgado L, Pedro E, Branco-Ferreira M; Portuguese Society of Allergology and Clinical Immunology (SPAIC) Anaphylaxis Interest Group. Anaphylaxis in children and adolescents: The Portuguese Anaphylaxis Registry. Pediatr Allergy Immunol. 2021 Aug;32(6):1278-1286. doi: 10.1111/pai.13511. Epub 2021 Apr 18.

  PMID: 33774834 BACKGROUND

• Muraro A, Worm M, Alviani C, Cardona V, DunnGalvin A, Garvey LH, Riggioni C, de Silva D, Angier E, Arasi S, Bellou A, Beyer K, Bijlhout D, Bilo MB, Bindslev-Jensen C, Brockow K, Fernandez-Rivas M, Halken S, Jensen B, Khaleva E, Michaelis LJ, Oude Elberink HNG, Regent L, Sanchez A, Vlieg-Boerstra BJ, Roberts G; European Academy of Allergy and Clinical Immunology, Food Allergy, Anaphylaxis Guidelines Group. EAACI guidelines: Anaphylaxis (2021 update). Allergy. 2022 Feb;77(2):357-377. doi: 10.1111/all.15032. Epub 2021 Sep 1.

  PMID: 34343358 BACKGROUND

• Cardona V, Ansotegui IJ, Ebisawa M, El-Gamal Y, Fernandez Rivas M, Fineman S, Geller M, Gonzalez-Estrada A, Greenberger PA, Sanchez Borges M, Senna G, Sheikh A, Tanno LK, Thong BY, Turner PJ, Worm M. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020 Oct 30;13(10):100472. doi: 10.1016/j.waojou.2020.100472. eCollection 2020 Oct.

  PMID: 33204386 BACKGROUND

MeSH Terms

Conditions

Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Aykut Çağlar

  Aydın Adnan Menderes University Hospital, Department of Pediatric Emergency Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: May 1, 2014
• Primary Completion: November 1, 2024
• Study Completion: October 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share