Blood, urine, and stool mercury levels in premature and LBW infants receiving thimerosal-containing vaccines

Condition
Premature Infant Low Birth Weight Infant

Further Study Details: 

Expected Total Enrollment:  72

The primary objective is to describe the levels of mercury in the blood of premature newborns > 32 and < 37 weeks gestation and birth weight > 2000 but < 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 BBG immunization, and to evaluate the excretion of mercury in these newborns by examining mercury levels in stool and urine.

Ages Eligible for Study:  32 Weeks   -   37 Weeks,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Inclusion Criteria

1. Parent/guardian gives written informed consent.
2. 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).
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:

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.Exclusion Criteria

Please refer to this study by ClinicalTrials.gov identifier  NCT00138333

Michael Pichichero      (585) 244-9720    mep@rochester.rr.com

New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States
Argentina
      Hospital de Ninos, "Ricardo Gutierrez", Buenos Aires,  1426,  Argentina

Study ID Numbers:  04-046
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