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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03708250
Other study ID # CHUBX 2018/54
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date May 31, 2018

Study information

Verified date April 2023
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. There are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. The main objective of this study is to precisely describe poisoning cases by button battery in order to propose a better management


Description:

Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. The most serious cases are those related to the ingestion of button cells, especially in children, when the battery gets stuck in the esophagus. Poison control centres, as well as addictovigilance centres, are regularly called upon for serious poisoning resulting in hospitalization, for which precisely description is most often missing or difficult to obtain and limits the efficiency of the management of these poisonings. So there are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. For example, in many cases, there is a lack of detail of initial symptoms, delays between symptoms and completion of further tests, follow-ups… A prospective and descriptive study about button battery poisoning performed on data collected by French PCC will be conducted between the 1st June of 2016 and the 31 May of 2018: any call in a PCC that occurred during the period studied and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology will be included. The following data will be taken : severe complication, need for surgery, length of hospital stay, death, risk factors concerning the battery (size, voltage), abnormalities at the first fibroscopy.


Recruitment information / eligibility

Status Completed
Enrollment 510
Est. completion date May 31, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Any call that occurred during the period studied in a Poison Control Centre and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology. Exclusion Criteria: Animal cases

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Anti Poison Angers
France Centre Anti Poison Lille
France Centre Anti Poison Lyon
France Centre Anti Poison Marseille
France Centre Anti Poison Nancy
France Centre Anti Poison Paris
France Centre Anti Poison Strasbourg
France Centre Anti Poison Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary occurrence of a serious complication occurrence of a serious complication Baseline
Secondary Need for surgery Need for surgery baseline
Secondary Length of hospital stay Length of hospital stay baseline
Secondary Death Death baseline
Secondary Battery Size Battery Size baseline
Secondary Battery Voltage Battery Voltage baseline
Secondary Presence of Lying Presence of Lying baseline
Secondary Length of Insertion Length of Insertion baseline
Secondary Abnormalities at First Fibroscopy Abnormalities at First Fibroscopy baseline