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

This study is currently recruiting participants.
Verified May 2013 by Cornell University
Sponsor:
Information provided by (Responsible Party):
Cornell University
ClinicalTrials.gov Identifier:
NCT01699841
First received: October 2, 2012
Last updated: May 21, 2013
Last verified: May 2013

October 2, 2012
May 21, 2013
April 2012
July 2013   (final data collection date for primary outcome measure)
Breast milk composition [ Time Frame: Up to 6 months post-partum ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Infant infectious disease events [ Time Frame: Up to 6 months of age ] [ Designated as safety issue: No ]
Same as current
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Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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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
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HIV+ and HIV- mothers and their infants
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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:

  • None
Both
Not Provided
Yes
Contact: Joann M. McDermid, PhD 607-255-2490 jmm585@cornell.edu
Tanzania
 
NCT01699841
IRB 1111002616
No
Cornell University
Cornell University
Not Provided
Not Provided
Cornell University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP