Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events
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The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.
Condition |
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HIV Malnutrition Cryptosporidiosis |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- Breast milk composition [ Time Frame: Up to 6 months post-partum ] [ Designated as safety issue: No ]
- Infant anthropometric measures [ Time Frame: Up to 6 months of age ] [ Designated as safety issue: No ]
- Infant infectious disease events [ Time Frame: Up to 6 months of age ] [ Designated as safety issue: No ]
Estimated Enrollment: | 208 |
Study Start Date: | April 2012 |
Groups/Cohorts |
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HIV+ and HIV- mothers and their infants |
![](https://webarchive.library.unt.edu/web/20130309094845im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HIV+ and HIV- mothers and their infants attending a semi-rural clinic and/or rural dispensaries from birth to 6 months of infant age in north western Tanzania.
Inclusion Criteria:
- Informed consent provided by mothers, and parental consent on behalf of their infants
- Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
- Stated intention to remain in the clinic catchment area ≥6 months post-partum
- Singleton birth
Exclusion Criteria:
- None
![](https://webarchive.library.unt.edu/web/20130309094845im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Joann M. McDermid, PhD | 607-255-2490 | jmm585@cornell.edu |
Tanzania | |
Kisesa Health Centre | Recruiting |
Kisesa, Tanzania | |
Contact: Joann M. McDermid, PhD 607-255-2490 jmm585@cornell.edu | |
Principal Investigator: Joann M. McDermid, PhD |
![](https://webarchive.library.unt.edu/web/20130309094845im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Cornell University |
ClinicalTrials.gov Identifier: | NCT01699841 History of Changes |
Other Study ID Numbers: | IRB 1111002616 |
Study First Received: | October 2, 2012 |
Last Updated: | October 2, 2012 |
Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
Communicable Diseases Cryptosporidiosis Malnutrition Infection Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections, Animal |
Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Nutrition Disorders |
ClinicalTrials.gov processed this record on March 07, 2013