Clinical Trials Logo

Clinical Trial Summary

Infant lead poisoning is the clinical expression of lead poisoning. This environmental disease, still present in France, is the only notifiable non-infectious disease.

Its complications include, in the foreground, disorders of psychomotor development but also include in adults the attack of other systems.

The fight against lead poisoning mainly involves the removal of lead sources. Several methods of eviction exist: a modification of the practices, a palliative rehabilitation, a definitive rehabilitation and a relocation. The effectiveness of each method is not documented. This study therefore aims to compare the effectiveness of these various measures to eliminate the risk of exposure to lead on blood lead.

This study uses the methodology of a multicenter historical cohort. It will begin in the second quarter of 2017. The research centers will be child-environment consultations and mother-child PASS in Avignon, Manosque, Marseille, Nice and Toulon.

The study will be offered to all children monitored in these centers since 2011. The inclusion criteria will include: age <18 years, at least one blood lead ≥ 50μg.L-1, residence declared in PACA and absence opposition. The retrospective data will be incorporated into the prospective monitoring. The necessary number is at least 165 cases of infantile lead poisoning (of which 33 per type of intervention). The primary endpoint will be the kinetics of quarterly venous blood lead. The smallest clinically significant difference in blood lead levels will be 50μg.L-1 between the different groups.

Statistical analysis will use intra- and inter-individual variability analysis by compartmental modeling of the pharmacokinetics of blood lead. An interim analysis will be conducted in 2017 on the retrospective data to confirm the necessary staffing.


Clinical Trial Description

Infant lead poisoning is the clinical expression of lead poisoning. This environmental disease, still present in France, is the only notifiable non-infectious disease.

Its complications include, in the foreground, disorders of psychomotor development (behavioral disorders, attention, memory ...) but also include in adults the attack of other systems (kidney disorders, fertility disorders and complications). obstetric).

The fight against lead poisoning mainly involves the removal of lead sources. Several methods of eviction exist: a modification of the practices, a palliative rehabilitation, a definitive rehabilitation and a relocation. The effectiveness of each method is not documented. This study therefore aims to compare the effectiveness of these various measures to eliminate the risk of exposure to lead on blood lead.

Material and methods: This study uses the methodology of a multicenter historical cohort. It will begin in the second quarter of 2017. The research centers will be child-environment consultations and mother-child PASS in Avignon, Manosque, Marseille, Nice and Toulon.

The study will be offered to all children monitored in these centers since 2011. The inclusion criteria will include: age <18 years, at least one blood lead ≥ 50μg.L-1, residence declared in PACA and absence opposition. The retrospective data will be incorporated into the prospective monitoring. The necessary number is at least 165 cases of infantile lead poisoning (of which 33 per type of intervention). The primary endpoint will be the kinetics of quarterly venous blood lead. The smallest clinically significant difference in blood lead levels will be 50μg.L-1 between the different groups.

Statistical analysis will use intra- and inter-individual variability analysis by compartmental modeling of the pharmacokinetics of blood lead. An interim analysis will be conducted in 2017 on the retrospective data to confirm the necessary staffing. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03640143
Study type Observational
Source Assistance Publique Hopitaux De Marseille
Contact REMI LAPORTE, MD
Phone +33 491368813
Email RemiJulien.LAPORTE@ap-hm.fr
Status Not yet recruiting
Phase
Start date November 2018
Completion date December 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT02553070 - Health Professions Students and Faculty Perceptions of Poisoning Severity N/A
Recruiting NCT05215457 - Severity Index of Diquat Poisoning in Evaluating the Prognosis of Acute Diquat Poisoning
Completed NCT00015600 - Community-Based Environmental Health Intervention N/A
Recruiting NCT05098418 - Trends of Acute Intoxication in Poison Control Centre
Not yet recruiting NCT03314909 - Initial Hemopurification Strategy for Acute Paraquat Poisoning in Adults N/A
Not yet recruiting NCT05229419 - Pattern of Acute Pediatric Poisoning at Assiut University Hospitals
Completed NCT04653597 - Non-invasive Airway Management of Comatose Poisoned Emergency Patients Phase 3
Completed NCT00013754 - Pesticide Exposure Pathways for Farmworker Children N/A
Completed NCT04217070 - Suicidal Poisoning in Emergency Units
Withdrawn NCT03894306 - Understanding How Medication is Stored in the Home
Completed NCT00013767 - Community Based Prevention/Control Project N/A
Not yet recruiting NCT04729894 - Evaluating the Impact of a Safe Medication Storage Device N/A
Completed NCT01209455 - Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects N/A
Recruiting NCT04850014 - PBPK Modelling Applied to Acetaminophen Poisoned Obese Children