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

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ClinicalTrials.gov Identifier: NCT01699841
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Cornell University

Study Description
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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.

Condition or disease
HIV Malnutrition Cryptosporidiosis

Study Design
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Study Type : Observational
Estimated Enrollment : 208 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : April 2012
Actual Primary Completion Date : June 15, 2013
Actual Study Completion Date : June 30, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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


Outcome Measures
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Primary Outcome Measures :
  1. Breast milk composition [ Time Frame: Up to 6 months post-partum ]

Secondary Outcome Measures :
  1. Infant anthropometric measures [ Time Frame: Up to 6 months of age ]
  2. Infant infectious disease events [ Time Frame: Up to 6 months of age ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699841


Locations
Tanzania
Kisesa Health Centre
Kisesa, Tanzania
Sponsors and Collaborators
Cornell University
More Information
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01699841     History of Changes
Other Study ID Numbers: IRB 1111002616
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

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