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

Completed

• Conditions: HIV; Malnutrition; Cryptosporidiosis

• Registration Number: NCT01699841
• Lead Sponsor: Cornell University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Primary Completion: 2013-06-15
• Study Completion: 2013-06-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast milk composition	Up to 6 months post-partum

Secondary Outcome Measures

Name	Time	Method
Infant infectious disease events	Up to 6 months of age
Infant anthropometric measures	Up to 6 months of age

Trial Locations

Locations (1)

Kisesa Health Centre; 🇹🇿 Kisesa, Tanzania