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

NCT03640143 | Not Yet Recruiting

• 1 other identifier: 2017-51
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poisoning

Outcome Measures

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.

  3 years

Study Arms (1)

experimental group

children with clinical expression of lead poisoning data about venous blood lead will be reported

Other: venous blood lead

Interventions

venous blood lead OTHER

data about ve,nous blood lead

experimental group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

childrem presenting clinical characteristic of poisoning

You may qualify if:

• 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,

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publiquye Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Poisoning

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

REMI LAPORTE, MD

CONTACT

+33 491368813; RemiJulien.LAPORTE@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: November 1, 2018
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

FR (1)