Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Cornell University.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Cornell University
ClinicalTrials.gov Identifier:
NCT01699841
First Posted: October 4, 2012
Last Update Posted: November 24, 2014
Information provided by (Responsible Party):
Cornell University
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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 ]
Secondary Outcome Measures:
- Infant anthropometric measures [ Time Frame: Up to 6 months of age ]
- Infant infectious disease events [ Time Frame: Up to 6 months of age ]
| 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
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
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): 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 |
| First Submitted: | October 2, 2012 |
| First Posted: | October 4, 2012 |
| Last Update Posted: | November 24, 2014 |
| Last Verified: | November 2014 |
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 |