Mercury Levels in Premature and LBW Infants Receiving Thimerosal-Containing Vaccines - Article
Clinical Trial: Mercury Levels in Premature and LBW Infants Receiving Thimerosal-Containing Vaccines
This study is not yet open for patient recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) May 2005
|Premature Infant |
Low Birth Weight Infant
MedlinePlus consumer health information
Study Type: Observational
Study Design: Cross-Sectional, Prospective Study
Expected Total Enrollment: 72
Expected completion: June 2005
Accepts Healthy Volunteers
- Parent/guardian gives written informed consent.
- Good health as determined by negative gestational history, subjects 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).
- Newborn cohort: within 3 days of birth and gestational age >32 weeks and < 37 weeks and a birth weight > 2000 grams and < 3000 grams.
- Able to attend the scheduled visits and to comply with the study procedures.
- Infant history of vaccinations and date received is unknown or undocumented.
- Known history of high-level mercury exposure in mother or infant.
- Any contraindication to routine vaccinations.
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- HIV-positive mother by history.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay or neurological disorders.Exclusion Criteria
Location and Contact Information
University of Rochester Medical Center, Rochester, New York, 14642, United States
Hospital de Ninos, "Ricardo Gutierrez", Buenos Aires, 1426, Argentina
Last Updated: August 29, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00138333
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30