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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:
ClinicalTrials.gov Identifier:
NCT01699841
First Posted: October 4, 2012
Last Update Posted: November 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cornell University
October 2, 2012
October 4, 2012
November 24, 2014
April 2012
July 2013   (Final data collection date for primary outcome measure)
Breast milk composition [ Time Frame: Up to 6 months post-partum ]
Same as current
Complete list of historical versions of study NCT01699841 on ClinicalTrials.gov Archive Site
  • Infant anthropometric measures [ Time Frame: Up to 6 months of age ]
  • Infant infectious disease events [ Time Frame: Up to 6 months of age ]
Same as current
Not Provided
Not Provided
 
Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events
Not Provided
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • HIV
  • Malnutrition
  • Cryptosporidiosis
Not Provided
HIV+ and HIV- mothers and their infants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
208
Not Provided
July 2013   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
 
NCT01699841
IRB 1111002616
No
Not Provided
Not Provided
Cornell University
Cornell University
Not Provided
Not Provided
Cornell University
November 2014