Foreign Body IngestionCOCENCT05261074
Foreign Body Ingestion During COVID-19 Lockdown
An observational study of Foreign Body Ingestion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Ingestion of foreign bodies (FB) is one of the most observed domestic accidents and a frequent reason for consultation in pediatric emergency departments (PED). In the United States, nearly 100,000 ingestions of FB have been recorded by the National Poison Data System (NPDS), which represented the 4th cause of… Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Foreign Body Ingestion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2021to 20 Oct 2022
- 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 15 years
- All sexes
- Child
Study population: Child who consulted in the pediatric emergency department of Louis-Mourier University Hospital for ingestion of foreign bodies coded in Urqual software.
Who may be able to join
- Children <15 years old.
- Child who consulted in the pediatric emergency department of Louis-Mourier University Hospital.
- For ingestion of foreign bodies coded in Urqual software.
Who cannot join
- Refusal to participate in the study
- unusable files (> 20% missing data out of a total of 40 major items),
- Ingestion of CE was suspected but not confirmed,
- Ingestion of caustics or other chemicals,
- Introduced from an FB into the digestive tract by a route other than the oral cavity.
Trial locations and contacts
1 site in 1 country.
Naim DRID, MD contact
France1 site, 1 recruiting
- Recruiting
Louis Mourier Hospital - Assistance Publique Hopitaux de Paris
Colombes, 92025
Jerome VIALA, MD, PhD, +33140035712, jerome.viala@aphp.fr
Romain BASMACI, MD, PhD
About this study
Official title: Impact of COVID-19 Confinement on Foreign Body Ingestion in the Pediatric Emergency Department
Ingestion of foreign bodies (FB) is one of the most observed domestic accidents and a frequent reason for consultation in pediatric emergency departments (PED). In the United States, nearly 100,000 ingestions of FB have been recorded by the National Poison Data System (NPDS), which represented the 4th cause of intoxication in 2015.
Ingestion of FB involves very different mechanisms in children and adult patients. Unlike adults, 98% of FB ingestions in children are accidental and involve common objects found at home environment. Ingested FBs are of many types and vary depending on the object composition of the child's environment and supervision. The lockdown for COVID-19 pandemic highly modified children environment and parent supervision. Children remained at home and parents lived at home for teleworking.
Read more
In this study, the modifications of children environment that could affect epidemiology of FB ingestion will be evaluated. This is a retrospective study with a sample of around > 100 children of Louis Mourier hospital from January 1 to December 31, 2019 and from March 1 to May 31, 2020. The total duration of the study is planned for 10 months.
Primary outcomes:
- To determine the role of COVID-19 pandemic linked containment on the prevalence of FB ingestions in children.
Secondary outcomes:
- Describe the epidemiological-clinical, radiological, therapeutic and evolutionary characteristics of the FB consultant's ingestions in the emergency department
- Determine the frequency of endoscopy or surgery
- Determine the factors favoring the use of endoscopic extraction From March 16 to May 10, 2020.
Read the detailed description
To analyze the impact of COVID-19 lockdown in 2020 on FB ingestion by children, to compare epidemiology of FB ingestion during 3 periods: 2020 lockdown (March to May 2020), the entire 2019 year and March to May 2019. The anonymized data will be entered in Epidata software and data transfer secured using APHP servers.
The variables of interest will include: sex, age at the time of ingestion, type of the FB, single or multiple ingestion, annual period of ingestion, ingestion schedule, existence of a witness, time of arrival at the emergency room, presence and nature of clinical symptoms of ingestion, position of the FB in the digestive tract, complications of this ingestion, x-ray exams used to locate FB need for an extraction gesture, nature of this gesture, completion time, successes and complications of extraction.
The population should have an estimated number of between 100-150 children. Descriptive statistics. The quantitative variables will be described as mean and standard deviation or as median, quartiles, minimum and maximum depending on whether their distribution is Gaussian or not. The qualitative variables will be described in numbers (percentage).
Comparison tests. Qualitative data will be analyzed using Chi2 or Fischer's exact test.
The study was approved by hospital's ethics committee.
- Conditions
- Foreign Body Ingestion
- Being tested
- No intervention
- Keywords
- Foreign body, Children, Covid-19, Oesophagus
- Medical subject headings
- Foreign Bodies, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention (retrospective study)
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of foreign body (FB) ingestions in children
To determine the role of COVID-19 pandemic linked containment on the prevalence of foreign body (FB) ingestions in children
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start20 Oct 2021
- Primary completion20 Oct 2022 (estimated)
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign Body IngestionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerôme VIALA, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261074
- Sponsor's protocol ID
- APHP-COCE
- Acronym
- COCE
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Confinement on Foreign Body Ingestion in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT05261074
- Acronym / sponsor ID
- COCE / APHP-COCE
- Conditions
- Foreign Body Ingestion
- Keywords
- Foreign body, Children, Covid-19, Oesophagus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 2 Mar 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.
Ingestion of foreign bodies (FB) is one of the most observed domestic accidents and a frequent reason for consultation in pediatric emergency departments (PED). In the United States, nearly 100,000 ingestions of FB have been recorded by the National Poison Data System (NPDS), which represented the 4th cause of intoxication in 2015.
Ingestion of FB involves very different mechanisms in children and adult patients. Unlike adults, 98% of FB ingestions in children are accidental and involve common objects found at home environment. Ingested FBs are of many types and vary depending on the object composition of the child's environment and supervision. The lockdown for COVID-19 pandemic highly modified children environment and parent supervision. Children remained at home and parents lived at home for teleworking.
In this study, the modifications of children environment that could affect epidemiology of FB ingestion will be evaluated. This is a retrospective study with a sample of around > 100 children of Louis Mourier hospital from January 1 to December 31, 2019 and from March 1 to May 31, 2020. The total duration of the study is planned for 10 months.
Primary outcomes:
- To determine the role of COVID-19 pandemic linked containment on the prevalence of FB ingestions in children.
Secondary outcomes:
- Describe the epidemiological-clinical, radiological, therapeutic and evolutionary characteristics of the FB consultant's ingestions in the emergency department
- Determine the frequency of endoscopy or surgery
- Determine the factors favoring the use of endoscopic extraction From March 16 to May 10, 2020.
Detailed description
To analyze the impact of COVID-19 lockdown in 2020 on FB ingestion by children, to compare epidemiology of FB ingestion during 3 periods: 2020 lockdown (March to May 2020), the entire 2019 year and March to May 2019. The anonymized data will be entered in Epidata software and data transfer secured using APHP servers.
The variables of interest will include: sex, age at the time of ingestion, type of the FB, single or multiple ingestion, annual period of ingestion, ingestion schedule, existence of a witness, time of arrival at the emergency room, presence and nature of clinical symptoms of ingestion, position of the FB in the digestive tract, complications of this ingestion, x-ray exams used to locate FB need for an extraction gesture, nature of this gesture, completion time, successes and complications of extraction.
The population should have an estimated number of between 100-150 children. Descriptive statistics. The quantitative variables will be described as mean and standard deviation or as median, quartiles, minimum and maximum depending on whether their distribution is Gaussian or not. The qualitative variables will be described in numbers (percentage).
Comparison tests. Qualitative data will be analyzed using Chi2 or Fischer's exact test.
The study was approved by hospital's ethics committee.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Child who consulted in the pediatric emergency department of Louis-Mourier University Hospital for ingestion of foreign bodies coded in Urqual software.
Key inclusion criteria (3 listed)
- Children <15 years old.
- Child who consulted in the pediatric emergency department of Louis-Mourier University Hospital.
- For ingestion of foreign bodies coded in Urqual software.
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- unusable files (> 20% missing data out of a total of 40 major items),
- Ingestion of CE was suspected but not confirmed,
- Ingestion of caustics or other chemicals,
- Introduced from an FB into the digestive tract by a route other than the oral cavity.
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 |
|---|---|---|
| No interventionNo intervention (retrospective study) | Other | – |
Primary outcome
Prevalence of foreign body (FB) ingestions in children
Time frame: 1 year
To determine the role of COVID-19 pandemic linked containment on the prevalence of foreign body (FB) ingestions in children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- 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.
Naim DRID, MD contact
Jerôme VIALA, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
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 Foreign Body Ingestion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 2 Mar 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerôme VIALA, MD, PhD (+33140035712, jerome.viala@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of foreign body (FB) ingestions in children (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2022.