Background WHO guidelines recommend co-trimoxazole prophylaxis for HIV-exposed, HIV-uninfected infants. These guidelines date back to an era in which HIV testing of infants was impossible and mothers had poor access to antiretroviral treatment. To determine whether this guideline requires revision in the current era of effective prevention of mother-to-child transmission and early infant diagnosis programmes, we aimed to investigate whether receiving no co-trimoxazole prophylaxis is inferior to receiving co-trimoxazole prophylaxis in the resulting incidence of grade 3 or 4 common childhood illnesses or mortality in breastfed HIV-exposed, HIV-uninfected infants. MethodsWe investigated our aim in a randomised controlled, non-inferiority trial. We enrolled the HIV-negative infants of mothers living with HIV who were actively involved in transmission prevention programmes in two clinics in Durban, South Africa. Infants were included in the study if they were breastfeeding at the screening and enrolment visits, and their mother was planning to breastfeed for at least 6 months; were a singleton birth and had a birthweight of 2 kg or more; had no clinically observed genetic disorders; and had no serious illnesses and had not received antibiotics or traditional medications (such as herbal remedies). Infants were randomly assigned (1:1) to receive co-trimoxazole or no co-trimoxazole. In the co-trimoxazole group, infants received the drug until all exposure to HIV had ceased (ie, 6 weeks after last exposure to breastmilk) and the infant was confirmed to be uninfected with HIV. The drug was administered by mothers in once-daily regimens of 20 mg trimethoprim and 100 mg sulfamethoxazole orally (age <6 months or bodyweight <5 kg), or 40 mg trimethoprim and 200 mg sulfamethoxazole orally (age >6 months or bodyweight >5 kg). Clinical and laboratory staff always remained masked to group assignment, but mothers and study counsellors were not. Infants and their mothers attended study visits at ages 6 weeks (for enrolment and randomisation), 10 weeks, 14 weeks, and then monthly from 4 to 12 months. Our primary outcome was the incidence of grade 3 or 4 common childhood illnesses (pneumonia or diarrhoea) or mortality in breastfed HIV-exposed, HIV-uninfected infants by age 12 months. A non-inferiority bound of 5% was used. The study is registered with the Pan African Clinical Trials Registry, number PACTR201311000621110, and the South African National Clinical Trials Registry, number DOH-27-0614-4728. Findings We screened 1570 mother-child pairs for study enrolment, from whom (78%) eligible infants were enrolled into the study between Oct 16, 2013, and May 23, 2018. Of the infants enrolled, 611 (50%) were randomly assigned to the co-trimoxazole group and 609 (50%) were randomly assigned to the no co-trimoxazole group. One (<1%) infant in the no co-trimoxazole group was excluded from the analysis of the final outcomes for having received traditional medicine (which only became apparent after randomisation); therefore, 611 (50%) infants...

BackgroundMaternal recall is most commonly used to determine exclusive breastfeeding rates. A gold standard stable isotope method is available which can determine intake of breast milk versus water from sources other than breast milk and thus objectively determine exclusive breastfeeding. The objectives of this study were to determine exclusive breastfeeding rates by both maternal recall and the objective stable isotope method and discuss the limitations and usefulness of the two methods.MethodsThe study involved 100 mother-infant pairs in a peri-urban area in Durban, South Africa and study visits took place from July 2012 to September 2014. Maternal recall of exclusive breastfeeding was carried out using the World Health Organization’s 24 hour recall of infant feeding and this was compared to the objective measurement of exclusive breastfeeding using the stable isotope technique at three time points: six weeks, three and 5.5 months. The objective measurements were carried out using two different cut off values for exclusive breastfeeding. Kappa analysis was used to quantify the relationship between maternal recall and results from the stable isotope technique for each mother-infant pair.ResultsOver reporting of exclusive breastfeeding was common at the three different time points regardless of the cut off value used to assess exclusive breastfeeding by the stable isotope technique. Kappa analysis also revealed only slight or fair agreement (K < 0.24) between reported and measured exclusive breastfeeding at all time points.ConclusionsMaternal recall of exclusive breastfeeding is limited in accuracy and should be restricted to large scale epidemiological surveys. The more objective gold standard stable isotope method for measuring intake volumes of breast milk should be used to evaluate interventions with smaller representative samples.

This study using objective methodology shows that breastmilk outputs of HIV-infected mothers were relatively high (and within published reference ranges), and mothers are able to provide sufficient breastmilk for their infants without compromising their own fat-free mass.

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