ChildNCT07231393
Observation Periods and Biphasic Reaction Risk Factors in Pediatric Emergency Anaphylaxis Cases
An observational study of Child and Anaphylaxis, run by Aydin Adnan Menderes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 17 years
- Conditions the study is for
- Child, Anaphylaxis, Pediatric Emergency Care
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Age <18 years
- Diagnosis of anaphylaxis according to World Allergy Organization (WAO) 2020 criteria
- Complete clinical data available in medical records
Who cannot join
- Incomplete or missing clinical data
- Cases not meeting WAO 2020 anaphylaxis definition
- Patients presenting with isolated urticaria or localized allergic reactions only
About this study
Official title: Evaluation of Observation Periods and Biphasic Reaction Risk Factors in Pediatric Anaphylaxis Cases in the Pediatric Emergency Department: A Retrospective Study
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.
Read the detailed description
Anaphylaxis is a severe, potentially life-threatening systemic hypersensitivity reaction with rapid onset. Its incidence in children has been rising worldwide. Although international recommendations emphasize the importance of post-reaction monitoring, the optimal observation period in pediatric patients remains uncertain, largely due to the risk of biphasic reactions, defined as recurrence of symptoms after initial resolution within 1-72 hours.
This retrospective observational study was conducted in the Pediatric Emergency Department of Adnan Menderes University Hospital. All patients younger than 18 years who presented with anaphylaxis between January 1, 2014, and December 31, 2024, were included. Diagnosis was based on the World Allergy Organization (WAO) 2020 criteria. Data were obtained from electronic medical records and emergency department charts.
Collected variables included demographics (age, sex), season of presentation, suspected triggers (food, drug, insect sting, exercise, idiopathic), clinical manifestations (cutaneous, respiratory, cardiovascular, gastrointestinal, neurological), comorbidities (such as asthma), acute treatments (epinephrine administration, time to first dose, number of doses, corticosteroids, antihistamines, fluid therapy), observation duration, need for hospital admission, and occurrence of biphasic reactions.
The primary objective is to determine the incidence and timing of biphasic reactions. Secondary objectives are to assess the average observation period in the emergency department, the frequency of hospital admission, and risk factors associated with biphasic reactions, including delayed epinephrine administration and history of asthma. Statistical analysis will include descriptive methods, group comparisons, and logistic regression to identify independent predictors of biphasic reactions.
This study is expected to contribute real-world data on pediatric anaphylaxis and inform clinical practice regarding safe observation times. Results will be compared with existing evidence and may support improvements in pediatric emergency protocols for anaphylaxis management.
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours of the initial anaphylaxis episode
Secondary outcomes (2)
Mean Observation Period in the Pediatric Emergency Department
Average length of observation (in hours) in the pediatric emergency department following initial anaphylaxis management.
Measured: During index visit (hours)
Risk Factors Associated with Biphasic Reactions
Identification of independent predictors for biphasic reactions (e.g., history of asthma, delayed epinephrine administration, initial clinical severity, need for multiple epinephrine doses).
Measured: During index visit and follow-up within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 May 2014
- Primary completion30 Nov 2024
- Study completionOct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Çağlar, MD, Aydin Adnan Menderes University
- Investigators
- Aykut Çağlar, Principal investigator, Aydın Adnan Menderes University Hospital, Department of Pediatric Emergency Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231393
- Sponsor's protocol ID
- ADUPEDANAPH
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data. Summary results will be available in published articles.
Publications
Ayar M, Demir S, Sahin C, Caglar A. Pediatric Anaphylaxis in a Tertiary Pediatric Emergency Department: Observation Duration and Biphasic Reactions. Children (Basel). 2026 Sep 30;13(10):1334. doi: 10.3390/children13101334.
PubMed 42940653Soyak 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.
PubMed 39810830Gaspar 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.
PubMed 33774834Muraro 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.
PubMed 34343358Cardona 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.
PubMed 33204386
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Observation Periods and Biphasic Reaction Risk Factors in Pediatric Anaphylaxis Cases in the Pediatric Emergency Department: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07231393
- Acronym / sponsor ID
- ADUPEDANAPH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- Oct 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anaphylaxis is a severe, potentially life-threatening systemic hypersensitivity reaction with rapid onset. Its incidence in children has been rising worldwide. Although international recommendations emphasize the importance of post-reaction monitoring, the optimal observation period in pediatric patients remains uncertain, largely due to the risk of biphasic reactions, defined as recurrence of symptoms after initial resolution within 1-72 hours.
This retrospective observational study was conducted in the Pediatric Emergency Department of Adnan Menderes University Hospital. All patients younger than 18 years who presented with anaphylaxis between January 1, 2014, and December 31, 2024, were included. Diagnosis was based on the World Allergy Organization (WAO) 2020 criteria. Data were obtained from electronic medical records and emergency department charts.
Collected variables included demographics (age, sex), season of presentation, suspected triggers (food, drug, insect sting, exercise, idiopathic), clinical manifestations (cutaneous, respiratory, cardiovascular, gastrointestinal, neurological), comorbidities (such as asthma), acute treatments (epinephrine administration, time to first dose, number of doses, corticosteroids, antihistamines, fluid therapy), observation duration, need for hospital admission, and occurrence of biphasic reactions.
The primary objective is to determine the incidence and timing of biphasic reactions. Secondary objectives are to assess the average observation period in the emergency department, the frequency of hospital admission, and risk factors associated with biphasic reactions, including delayed epinephrine administration and history of asthma. Statistical analysis will include descriptive methods, group comparisons, and logistic regression to identify independent predictors of biphasic reactions.
This study is expected to contribute real-world data on pediatric anaphylaxis and inform clinical practice regarding safe observation times. Results will be compared with existing evidence and may support improvements in pediatric emergency protocols for anaphylaxis management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Age <18 years
- Diagnosis of anaphylaxis according to World Allergy Organization (WAO) 2020 criteria
- Complete clinical data available in medical records
Key exclusion criteria (3 listed)
- Incomplete or missing clinical data
- Cases not meeting WAO 2020 anaphylaxis definition
- Patients presenting with isolated urticaria or localized allergic reactions only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Biphasic Reactions
Time frame: Within 72 hours of the initial anaphylaxis episode
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.
2 secondary outcomes
Mean Observation Period in the Pediatric Emergency Department
Time frame: During index visit (hours)
Risk Factors Associated with Biphasic Reactions
Time frame: During index visit and follow-up within 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 42940653Ayar M, Demir S, Sahin C, Caglar A. Pediatric Anaphylaxis in a Tertiary Pediatric Emergency Department: Observation Duration and Biphasic Reactions. Children (Basel). 2026 Sep 30;13(10):1334. doi: 10.3390/children13101334.
- Background: PubMed 39810830Soyak 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.
- Background: PubMed 33774834Gaspar 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.
- Background: PubMed 34343358Muraro 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.
- Background: PubMed 33204386Cardona 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.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data. Summary results will be available in published articles.
Related trials for Child
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aykut Çağlar principal investigator
Aydın Adnan Menderes University Hospital, Department of Pediatric Emergency Care
Questions about this trial
What is this clinical trial studying?
An observational study of Child and Anaphylaxis, run by Aydin Adnan Menderes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Biphasic Reactions (time frame: Within 72 hours of the initial anaphylaxis episode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07231393, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.