Overview of Botriomycoma in Children with a Central Line: Epidemiology, Risk Factors, Treatments

NCT ID: NCT06708689

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-03-03

Brief Summary

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Botriomycomas are frequent benign tumors in children. Their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. This lesion could lead to changes in pathways and an increase in the number of sepsis events, which would promote thrombosis and thus depletion of venous capital in patients who have been dependent on a central line for many years.

This study is a pilot study which will enable us to better identify the risk factors for the development of such a tumour, and to take stock of the different treatments used and their respective efficacy.

Detailed Description

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Conditions

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Home Parenteral Nutrition Intestinal Failure Central Line Botriomycoma Infection Sepsis Antibiotics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case / patients

Pediatric patients requiring a long-term central line for home parenteral nutrition:

* home parenteral nutrition patients
* diagnosed with at least on episode of botriomycoma on their central line
* 0 to 18 years of age at diagnosis of botriomycoma

No interventions assigned to this group

Control

Pediatric patients requiring a long-term central line for home parenteral nutrition:

* home parenteral nutrition patients
* never diagnosed with an episode of botriomycoma on their central line
* 0 to 18 years of age at diagnosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* home parenteral nutrition patients
* never diagnosed with an episode of botriomycoma on their central line
* 0 to 18 years of age at diagnosis

Exclusion Criteria

* Botriomycoma more than 10 years old at time of data collection (or lack of data)
* Patient over 18 years of age
* Not on home parenteral nutrition patients
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Mère-Enfant

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL23_0638

Identifier Type: -

Identifier Source: org_study_id