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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00310726
Date of registration: 03/04/2006
Primary sponsor: Boston Medical Center
Public title: Zambia Exclusive Breastfeeding Study
Scientific title: Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission
Date of first enrolment: May 2001
Target sample size: 1435
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention  
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- HIV-positive pregnant women identified through VCT

- After counseling about the risks and benefits of feeding alternatives report that it
is their intended decision to breastfeed

- Live within the catchment area of George or Chawama clinic

- Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a
minimum of 2 lactation counseling sessions prior to delivery)

- Do not have any significant presenting illness that requires hospitalization

- Agree to adhere to the requirements of study participation (including exclusive
breastfeeding and randomization into one of two infant feeding groups at four

- Willing to inform a household member (preferably husband/father) of HIV-status.

Exclusion Criteria:

- Lives outside of catchment area;

- Have known major illnesses likely to influence pregnancy outcome including diabetes,
severe renal or heart disease, or active tuberculosis, prior to randomization;

- Does not intend to breastfeed;

- Prior enrollment in this study or concurrent enrollment in another study

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female
Health Condition(s) or Problem(s) studied
HIV Infection
Other: abrupt weaning at 4 months
Other: Continued exclusive breastfeeding
Primary Outcome(s)
HIV infection detected by 4 months among children with no evidence of HIV infection at birth. [Time Frame: 24 months of age]
Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institutes of Health (NIH)
United States Agency for International Development (USAID)
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