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

Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03640143
• Other study ID #: 2017-51
• Status: Not yet recruiting
• Start date: November 2018
• Est. completion date: December 2026

Study information

• Verified date: August 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: REMI LAPORTE, MD
• Phone: +33 491368813
• Email: RemiJulien.LAPORTE[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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,

• AND declared resident in PACA,

Exclusion Criteria:

• Patient:

• 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,

• OR declared resident outside Paca,

• OR for which an environmental intervention was carried out at an unknown date

• OR without a source of exposure found in France (eg first-time migrant child).

Related Conditions & MeSH terms

• Lead Poisoning
• Poisoning

Intervention

Other:
• venous blood lead
data about ve,nous blood lead

Locations

Country	Name	City	State
France	Assistance Publiquye Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years