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

This study is ongoing, but not recruiting participants.
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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant anthropometric measures [ Time Frame: Up to 6 months of age ] [ Designated as safety issue: No ]
  • Infant infectious disease events [ Time Frame: Up to 6 months of age ] [ Designated as safety issue: No ]
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
Genders Eligible for Study:   Both
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:

  • None
  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

No publications provided

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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cryptosporidiosis
Coccidiosis
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
 Intestinal Diseases, Parasitic
Parasitic Diseases
Parasitic Diseases, Animal
Protozoan Infections
Protozoan Infections, Animal

ClinicalTrials.gov processed this record on February 27, 2015