UnknownNot Applicable

Foreign Body Ingestion During COVID-19 Lockdown

France100 participantsStarted 2021-10-20

Plain-language 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 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.

Who can participate

Age range

1 Day – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of foreign body (FB) ingestions in children

Timeframe: 1 year

Trial details

NCT IDNCT05261074

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-10-20

Contact for this trial

Jerôme VIALA, MD, PhD

+33140035712 jerome.viala@aphp.fr

View on ClinicalTrials.gov More Foreign Body Ingestion trials