Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events
This study is ongoing, but not recruiting participants.
Sponsor:
Cornell University
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01699841
First received: October 2, 2012
Last updated: November 21, 2014
Last verified: November 2014
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Purpose
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 |
|---|
|
HIV Malnutrition Cryptosporidiosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Cornell University:
Primary Outcome Measures:
- Breast milk composition [ Time Frame: Up to 6 months post-partum ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| HIV+ and HIV- mothers and their infants |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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:
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699841
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699841
Locations
| Tanzania | |
| Kisesa Health Centre | |
| Kisesa, Tanzania | |
Sponsors and Collaborators
Cornell University
More Information
| 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: | November 21, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Malnutrition Cryptosporidiosis Nutrition Disorders Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections, Animal |
Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 30, 2016