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NCT01699841 Clinical Trial

Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events

HIV Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01699841
Other study ID # IRB 1111002616
Secondary ID
Status Completed
Phase N/A
First received October 2, 2012
Last updated October 30, 2017
Start date April 2012
Est. completion date June 30, 2013

Study information
Verified date October 2017
Source Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 208
Est. completion date June 30, 2013
Est. primary completion date June 15, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Tanzania Kisesa Health Centre Kisesa

Sponsors (1)
Lead Sponsor Collaborator
Cornell University

Country where clinical trial is conducted

Tanzania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Breast milk composition Up to 6 months post-partum
Secondary Infant anthropometric measures Up to 6 months of age
Secondary Infant infectious disease events Up to 6 months of age
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