PoisoningNCT05229419
Pattern of Acute Pediatric Poisoning at Assiut University Hospitals
An observational study of Poisoning, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Poisoning
- What is being tested?
- complete blood count
- How many people
- 359 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Feb 2023
- 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 1 day to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pattern of Acute Pediatric Poisoning at Assiut University Hospitals: Prospective Study
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.
Read the detailed description
In pediatric poisoning, the age, distribution, causes of poisoning and types of products involved differ between different geographical areas, even in the same area etiology and demographics of pediatric poisoning may change over the time depending on accessibility of poisoning to child, socioeconomic level, education, local beliefs, and customs. So, surveillance of epidemiology and patterns of children acute poisoning in each country is beneficial to define the scope of the problem and its management regarding prevention and treatment.
Acute pediatric poisoning may be unintentional (accidental, therapeutic error), or intentional (suicide, substance abuse). Unintentional poisoning is common in preschool age, mostly due to non-pharmaceutical agents, the most frequent agent of them is caustic ingestion according to Ain Shams Poison Control Center study. Caustic chemicals are widely distributed in our environment, caustic exposure is a lifelong and global problem associated with severe tissue and mucous membrane injuries with an estimated 80% of its exposure occurring among children. Caustic exposure is among the leading causes of mortality in those younger than 5 years, more than 15.8 cases per 100,000 children in the USA are reported annually, the situation is more severe in developing countries.
While the developed world has accurate demographic date about acute pediatric poisoning and its incidence, this major health problem is still insufficiently studied in the developing world and poorly documented. To knowledge, Assiut University Hospitals are lacking good demographic and epidemiological data regarding pediatric poisoning.
- Conditions
- Poisoning
- Being tested
- complete blood count
- Medical subject headings
- Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood countOther
complete blood count will be done for corrosive cases
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Determination of different causative agents by history, exposure route, if there is any time delay before coming to the hospital, clinical characteristics, whether the parent induced vomiting before seeking medical help or not, the outcome regarding mortality and morbidity, seasonal variation, and management data will be obtained. All of that data will be compared with each other in different pediatric age groups( infants < 1 year, toddlers 1-<3 years, preschool age 3-<6 years, school age 6-<12 years, adolescents 12-18 years) .
Measured: 1/2/2022 to 31/1/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Feb 2022
- Primary completion31 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PoisoningStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Ahmed Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229419
- Sponsor's protocol ID
- PAPTAUH
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26653953Berta 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.
PubMed 32527281Pianca 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.
PubMed 28886402Gummin 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.
PubMed 30576252Park 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.
PubMed 25133115Persson 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.
PubMed 9656975Rafeey 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.
PubMed 27757390Urganci 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.
PubMed 23918323Uygun 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.
PubMed 23175922
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Acute Pediatric Poisoning at Assiut University Hospitals: Prospective Study
- ClinicalTrials.gov ID
- NCT05229419
- Acronym / sponsor ID
- PAPTAUH
- Conditions
- Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 8 Feb 2022 (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.
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.
Detailed description
In pediatric poisoning, the age, distribution, causes of poisoning and types of products involved differ between different geographical areas, even in the same area etiology and demographics of pediatric poisoning may change over the time depending on accessibility of poisoning to child, socioeconomic level, education, local beliefs, and customs. So, surveillance of epidemiology and patterns of children acute poisoning in each country is beneficial to define the scope of the problem and its management regarding prevention and treatment.
Acute pediatric poisoning may be unintentional (accidental, therapeutic error), or intentional (suicide, substance abuse). Unintentional poisoning is common in preschool age, mostly due to non-pharmaceutical agents, the most frequent agent of them is caustic ingestion according to Ain Shams Poison Control Center study. Caustic chemicals are widely distributed in our environment, caustic exposure is a lifelong and global problem associated with severe tissue and mucous membrane injuries with an estimated 80% of its exposure occurring among children. Caustic exposure is among the leading causes of mortality in those younger than 5 years, more than 15.8 cases per 100,000 children in the USA are reported annually, the situation is more severe in developing countries.
While the developed world has accurate demographic date about acute pediatric poisoning and its incidence, this major health problem is still insufficiently studied in the developing world and poorly documented. To knowledge, Assiut University Hospitals are lacking good demographic and epidemiological data regarding pediatric poisoning.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute pediatric poisoning cases | – | Other: complete blood countAll 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complete blood countcomplete blood count will be done for corrosive cases | Other | acute pediatric poisoning cases |
Primary outcome
Incidence of acute pediatric poisoning by numbers in Assiut University Hospitals.
Time frame: 1/2/2022 to 31/1/2023
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 secondary outcome
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.
Time frame: 1/2/2022 to 31/1/2023
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 5 Aug 2024.
- Background: PubMed 26653953Azab 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.
- Background: PubMed 32527281Berta 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.
- Background: PubMed 28886402Pianca 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.
- Background: PubMed 30576252Gummin 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.
- Background: PubMed 25133115Park 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.
- Background: PubMed 9656975Persson 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.
- Background: PubMed 27757390Rafeey 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.
- Background: PubMed 23918323Urganci 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.
- Background: PubMed 23175922Uygun 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poisoning, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 5 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 acute pediatric poisoning by numbers in Assiut University Hospitals. (time frame: 1/2/2022 to 31/1/2023). 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 NCT05229419, which also lists 9 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 5 Aug 2024.