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Design
Randomised (allocation concealed*), blinded (investigators to interim results),* controlled trial with 2 year follow up.
Setting
4 antenatal clinics in Nairobi.
Patients
425 HIV-1 infected pregnant women (mean age 23 y) who resided in Nairobi and had access to municipally treated water. 401 mother-infant pairs (94%) were included in the analysis.
Intervention
Women were allocated to breast feed (n=212) or formula feed (n=213) their infants. Women in the formula feed group were told to feed their infant with a cup and had to demonstrate proper formula preparation and cup feeding to a visiting nurse.
Main outcome measures
Infant HIV-1 infection and mortality within the first 2 years. Mortality rates were compared using Kaplan-Meier survival analysis.
Main results
Analysis was by intention to treat. At 24 months, the cumulative probability of HIV-1 infection was higher in breastfed infants than in formula fed infants (p=0.001) (table
). A significant difference existed between breastfed and formula fed infants at all
Susan King, MD
Hospital for Sick Children Toronto, Ontario, Canada
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