Status:
COMPLETED
Mercury Levels in Premature and LBW Infants Receiving Thimerosal-containing Vaccines
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mercury Levels
Eligibility:
All Genders
32-36 years
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 i...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00138333
Start Date
December 1 2005
End Date
November 1 2006
Last Update
November 11 2011
Active Locations (1)
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1
Hospital de Ninos, "Ricardo Gutierrez"
Buenos Aires, Argentina, 1426