Botswana Diarrheal Diseases Study
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|ClinicalTrials.gov Identifier: NCT00197652|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 7, 2011
The goals of this study are to:
determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.
- analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
- comparison to rates among infants born to HIV uninfected mothers.
- link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1350 participants|
|Official Title:||Botswana Diarrheal Diseases Study|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||October 2003|
|Actual Study Completion Date :||March 2008|
Diarrheal specimens from infants born to HIV infected mothers
400 diarrheal specimens will suffice to determine the prevalence of specific pathogens in the region. Of these, 300 specimens will be collected from infants born to HIV infected mothers, and 100 specimens will be collected from infants born to HIV uninfected mothers.
Breast milk from HIV infected and HIV uninfected women
Breast milk from HIV infected and HIV uninfected women who are breastfeeding is collected at 2 days, 2 weeks, 2 months, and 5 months post-partum. This breast milk will be compared for in vitro functional quality of immunoglobulins to selected diarrheal and respiratory pathogens.
- OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197652
|Princess Marina Hospital|
|Principal Investigator:||Roger Shapiro, MD||Harvard School of Public Health|