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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2014 by Cornell University.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Cornell University

ClinicalTrials.gov Identifier:

NCT01699841

First received: October 2, 2012

Last updated: November 21, 2014

Last verified: November 2014

History of Changes

Purpose

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.

Condition
HIV Malnutrition Cryptosporidiosis


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Genetic and Rare Diseases Information Center resources: Cryptosporidiosis Coccidioidomycosis

U.S. FDA Resources

Further study details as provided by Cornell University:

Primary Outcome Measures:

Breast milk composition [ Time Frame: Up to 6 months post-partum ]

Secondary Outcome Measures:

Infant anthropometric measures [ Time Frame: Up to 6 months of age ]
Infant infectious disease events [ Time Frame: Up to 6 months of age ]


Estimated Enrollment:	208
Study Start Date:	April 2012
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
HIV+ and HIV- mothers and their infants

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

HIV+ and HIV- mothers and their infants attending a semi-rural clinic and/or rural dispensaries from birth to 6 months of infant age in north western Tanzania.

Criteria

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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699841

Locations


Tanzania
Kisesa Health Centre
Kisesa, Tanzania

Sponsors and Collaborators

Cornell University

More Information


Responsible Party:	Cornell University
ClinicalTrials.gov Identifier:	NCT01699841 History of Changes
Other Study ID Numbers:	IRB 1111002616
Study First Received:	October 2, 2012
Last Updated:	November 21, 2014

Additional relevant MeSH terms:


Malnutrition Cryptosporidiosis Nutrition Disorders Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections, Animal	Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on August 23, 2017

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