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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Malnutrition Cryptosporidiosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV+ and HIV- mothers and their infants

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kisesa Health Centre

Kisesa, , Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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IRB 1111002616

Identifier Type: -

Identifier Source: org_study_id