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

ConditionPoisoning
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

minor (under 18 years old),

AND having at least one blood lead ≥ 50 μg / l between 1/11/2011 and 31/12/2022,

AND with at least a subsequent check of blood lead,

AND having been seen at least once by a Child-Environment Consultation or a mother-child PASS in PACA,

Disqualifiers

with no blood lead ≥ 50 μg / l

OR adult at the time of diagnosis

OR opposed to participation (opposition of a parent or child served by mail)

OR without subsequent monitoring of blood lead,

Trial population

childrem presenting clinical characteristic of poisoning

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • venous blood lead

    Other intervention

    data about ve,nous blood lead

Treatment groups

165 Participants
are divided into 1 treatment group
Group A: experimental group1 intervention

Trial outcomes

Primary outcomes

1

venous blood lead

the kinetics of venous blood lead. The monitoring rhythm is recommended every 3 months in a medical analysis laboratory. The smallest clinically significant difference will be a decrease in blood lead level of 50 μg / l.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: