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

Cornell University

Status: Completed

Conditions: Cryptosporidiosis; Malnutrition; HIV

Study type: Observational

Funder types: Other

Identifiers

NCT01699841

IRB 1111002616

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

208 participants in 1 patient group

HIV+ and HIV- mothers and their infants