- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00138333
Mercury Levels in Premature and LBW Infants Receiving Thimerosal-containing Vaccines
November 10, 2011 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
Assessment of Mercury Levels and Metabolism in Premature and Low Birth Weight (LBW) Infants Receiving Vaccines Containing Thimerosal
The goal of the study is to find out how much mercury is in the blood, urine, and stools of premature and low birth weight infants who have received standard childhood vaccines that are given to all infants in Argentina.
Seventy-two newborn premature and low birth weight infants from Durand Acute General hospital will participate in this study.
Each infant in the study will need to make two visits, one at the time of vaccination and another 12 hours to 30 days later.
Urine, stool, and a small sample of blood will be taken at each visit.
Study Overview
Status
Completed
Conditions
Detailed Description
The primary objective is to describe the levels of mercury in the blood of premature newborns greater than or equal to 32 weeks and less than 37 weeks gestation and birth weight greater than or equal to 2000 grams but less than 3000 grams, who receive the routine birth dose of Hepatitis B immunization containing ethyl mercury in the form of thimerosal and the birth dose of BCG immunization, and to evaluate the excretion of mercury in these newborns by examining mercury levels in stool and urine.
Secondary objectives are: 1) to determine the half-time of mercury in blood following vaccination of premature and low birth weight infants with thimerosal-containing vaccines, and 2) to screen premature and low birth weight infants for evidence of early effects of thimerosal on the kidney by measurement of urinary gamma glutamyl transpeptidase levels.
All infants will have stool, urine, and blood samples collected prior to receipt of routine birth hepatitis B and BCG immunization.
Cord blood will serve as the baseline blood specimen.
Each infant will be seen once at a predetermined follow-up visit time point.
There will be 6 follow-up visit time points, with sampling from 12 infants at each time point.
All infants will provide blood, urine, and stool specimens at the assigned follow-up visit.
Study Type
Observational
Enrollment (Actual)
71
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1426
- Hospital de Ninos, "Ricardo Gutierrez"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 8 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: 1) Parent/guardian gives written informed consent.
2) Good health as determined by negative gestational history, subject's medical history and physical assessment.
Medical history will include a review of the major body systems (e.g., ear-nose-throat, cardiovascular, respiratory, neurological, gastrointestinal, genitourinary, hematological).
3) Newborn cohort: within 3 days of birth and gestational age = 32 weeks and < 37 weeks and a birth weight = 2000 grams and < 3000 grams.
4) Able to attend the scheduled visits and to comply with the study procedures.
Exclusion Criteria: 1) Infant history of vaccinations and date received is unknown or undocumented.
2) Known history of high-level mercury exposure in mother or infant.
3) Any contraindication to routine vaccinations.
4) Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
5) Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
6) HIV-positive mother by history.
7) Personal or immediate family history of congenital immune deficiency.
8) Developmental delay or neurological disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion
November 1, 2006
Study Registration Dates
First Submitted
August 26, 2005
First Submitted That Met QC Criteria
August 29, 2005
First Posted (Estimate)
August 30, 2005
Study Record Updates
Last Update Posted (Estimate)
November 11, 2011
Last Update Submitted That Met QC Criteria
November 10, 2011
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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