NCT03640143

Effectiveness of Environmental Measures to Eliminate the Risks of Lead Exposure in Infant Lead Poisoning

Effectiveness of Various Environmental Measures to Eliminate the Risks of Lead Exposure in Infant Lead Poisoning

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 165 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Poisoning

Interventions

Type	Name	Description
OTHER	venous blood lead	data about ve,nous blood lead

Timeline

• Start date: 2018-11-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2018-08-21
• Last updated: 2018-08-21

Locations

1 site across 1 country: France