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

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.

Completed

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Key information

Conditions

HIV Animal Diseases Coccidiosis Cryptosporidiosis Digestive System Diseases Gastrointestinal Diseases Infections Intestinal Diseases Intestinal Diseases, Parasitic Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Parasitic Diseases Parasitic Diseases, Animal Protozoan Infections Protozoan Infections, Animal

Sex eligibility

All sexes

Study type

Observational

Primary location

Kisesa Health Centre

Kisesa, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Breast milk composition

Time frame: Up to 6 months post-partum

Secondary outcomes

Infant anthropometric measures

Time frame: Up to 6 months of age
Infant infectious disease events

Time frame: Up to 6 months of age

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Oct 4, 2012
Registry last updated: Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed