NCT05229419

Brief Summary

Acute pediatric poisoning is a common worldwide problematic emergency and represents frequent cause of emergency department admissions throughout the world. In 2017, the 35th Annual Report of the American Association of Poison Control Centers' National Poison Data System referred more than 2 million calls for cases of human exposure to toxic substance, more than 50% of them occurred in children less than 13 years old. Also, about 1030 patients less than 14 years old were acutely intoxicated and presented to the Regina Margherita Hospital in Italy from 2012 to 2017. According to Ain Shams study during the period between 2009 and 2013, acute poisoning presented to Ain Shams Poison Control Center; accounts for an estimated 38,470 case among children less than or equals to 18 years old. In the same age group mentioned above, about 760 cases admitted to Menoufia Poison Control Center during the year 2016, those between 2 and 6 years represented the highest age group. Although pediatric poisoning represents a major and preventable cause of morbidity and mortality throughout the world, usually there is a great challenge with the management of acute pediatric poisoning due to the fact of difficult history taking, unreliable examination compared with that of an adult, in addition, pediatric patients are usually more vulnerable due to physiological difference between developmental stages. Also, the evident curiosity for the surroundings and the desire to explore and to emulate adults, make children particularly exposed to acute intoxications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 5, 2024

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

January 28, 2022

Last Update Submit

August 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute pediatric poisoning by numbers in Assiut University Hospitals.

    All cases of acute pediatric poisoning of both sexes, in age group less than or equals to 18 years old will presenting to Assiut University Hospitals with acute poisoning whose their adverse effects occurring following administration of single dose of a substance or multiple doses exposure within 24 hours will be included.

    1/2/2022 to 31/1/2023

Secondary Outcomes (1)

  • Correlation of acute poisoning in different pediatric age groups (from 0 to 18 years old) with each other as a plan for its appropriate prevention and management.

    1/2/2022 to 31/1/2023

Study Arms (1)

acute pediatric poisoning cases

All cases of acute pediatric poisoning of both sexes, in age group less than or equals to 18 years old will presenting to Assiut University Hospital with acute poisoning whose their adverse effects occurring following administration of single dose of a substance or multiple doses exposure within 24 hours.

Other: complete blood count

Interventions

complete blood count will be done for corrosive cases

acute pediatric poisoning cases

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All cases of acute pediatric poisoning of both sexes, in age group less than or equals to 18 years old presenting to Assiut University Hospitals with acute poisoning whose their adverse effects occurring following administration of single dose of a substance or multiple doses exposure within 24 hours.

You may qualify if:

  • Children (under or equals to 18 years old)
  • children with acute poisoning whose their adverse effects occurring following administration of single dose of a substance or multiple doses exposure within 24hours.

You may not qualify if:

  • \- Any child with the following Criteria will be excluded from our study;
  • Those with allergic reactions.
  • Those with foreign body ingestion (coins, plastics, or toys).
  • Those with chronic toxicity as lead poisoning.
  • Any child with other diseases will not be involved in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

Related Publications (9)

  • Azab SM, Hirshon JM, Hayes BD, El-Setouhy M, Smith GS, Sakr ML, Tawfik H, Klein-Schwartz W. Epidemiology of acute poisoning in children presenting to the poisoning treatment center at Ain Shams University in Cairo, Egypt, 2009-2013. Clin Toxicol (Phila). 2016;54(1):20-6. doi: 10.3109/15563650.2015.1112014.

    PMID: 26653953BACKGROUND
  • Berta GN, Di Scipio F, Bosetti FM, Mognetti B, Romano F, Carere ME, Del Giudice AC, Castagno E, Bondone C, Urbino AF. Childhood acute poisoning in the Italian North-West area: a six-year retrospective study. Ital J Pediatr. 2020 Jun 11;46(1):83. doi: 10.1186/s13052-020-00845-0.

    PMID: 32527281BACKGROUND
  • Pianca TG, Sordi AO, Hartmann TC, von Diemen L. Identification and initial management of intoxication by alcohol and other drugs in the pediatric emergency room. J Pediatr (Rio J). 2017 Nov-Dec;93 Suppl 1:46-52. doi: 10.1016/j.jped.2017.06.015. Epub 2017 Sep 5.

    PMID: 28886402BACKGROUND
  • Gummin DD, Mowry JB, Spyker DA, Brooks DE, Osterthaler KM, Banner W. 2017 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 35th Annual Report. Clin Toxicol (Phila). 2018 Dec;56(12):1213-1415. doi: 10.1080/15563650.2018.1533727. Epub 2018 Dec 21.

    PMID: 30576252BACKGROUND
  • Park KS. Evaluation and management of caustic injuries from ingestion of Acid or alkaline substances. Clin Endosc. 2014 Jul;47(4):301-7. doi: 10.5946/ce.2014.47.4.301. Epub 2014 Jul 28.

    PMID: 25133115BACKGROUND
  • Persson HE, Sjoberg GK, Haines JA, Pronczuk de Garbino J. Poisoning severity score. Grading of acute poisoning. J Toxicol Clin Toxicol. 1998;36(3):205-13. doi: 10.3109/15563659809028940.

    PMID: 9656975BACKGROUND
  • Rafeey M, Ghojazadeh M, Sheikhi S, Vahedi L. Caustic Ingestion in Children: a Systematic Review and Meta-Analysis. J Caring Sci. 2016 Sep 1;5(3):251-265. doi: 10.15171/jcs.2016.027. eCollection 2016 Sep.

    PMID: 27757390BACKGROUND
  • Urganci N, Usta M, Kalyoncu D, Demirel E. Corrosive substance ingestion in children. Indian J Pediatr. 2014 Jul;81(7):675-9. doi: 10.1007/s12098-013-1170-0. Epub 2013 Aug 7.

    PMID: 23918323BACKGROUND
  • Uygun I, Aydogdu B, Okur MH, Arayici Y, Celik Y, Ozturk H, Otcu S. Clinico-epidemiological study of caustic substance ingestion accidents in children in Anatolia: the DROOL score as a new prognostic tool. Acta Chir Belg. 2012 Sep-Oct;112(5):346-54. doi: 10.1080/00015458.2012.11680850.

    PMID: 23175922BACKGROUND

MeSH Terms

Conditions

Poisoning

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 8, 2022

Study Start

February 1, 2022

Primary Completion

January 31, 2023

Study Completion

February 1, 2023

Last Updated

August 5, 2024

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations