Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138333
Status:
COMPLETED
Last Update Posted:
2011-11-11
First Post:
2005-08-26
Brief Title:
Mercury Levels in Premature and LBW Infants Receiving Thimerosal-containing Vaccines
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Assessment of Mercury Levels and Metabolism in Premature and Low Birth Weight LBW Infants Receiving Vaccines Containing Thimerosal
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None