Poisoning Clinical Trial
Official title:
Effectiveness of Various Environmental Measures to Eliminate the Risks of Lead Exposure in Infant Lead Poisoning
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.
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.
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