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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01699841

Enrollment

208

Registered

2012-10-04

Start date

2012-04-30

Completion date

2013-06-30

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptosporidiosis, HIV, Malnutrition

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Breast milk composition	Up to 6 months post-partum

Secondary

Measure	Time frame
Infant anthropometric measures	Up to 6 months of age
Infant infectious disease events	Up to 6 months of age

Countries

Tanzania

Outcome results