Coovadia 2007.
| Methods | Non‐randomized intervention cohort study | |
| Participants | HIV‐infected and uninfected pregnant women attending antenatal clinics in KwaZulu Natal were enrolled into a non‐randomized intervention cohort study if they were 16 years of age or older, planned to stay in the study area for at least 3 months after delivery, and provided written informed consent. Uninfected women were included to establish the effect of HIV status on adherence to exclusive breastfeeding and other infant feeding practices. | |
| Interventions | Exclusive breastfeeding (antenatal counseling regarding infant feeding options, home visits 3‐4 times during first 2 weeks of life, and every 2 weeks thereafter until the infant was 6 months old. | |
| Outcomes | HIV status: 1276 infants with complete feeding data. 14.1 (95%CI: 12.0‐16.4) of exclusively breastfed infants infected with HIV by age 6 weeks and 19.5% (17.0‐22.4) by 6 months; the risk was significantly associated with maternal CD4 cell counts below 200 cells/mm3 (adjusted HR 3.79; 2.35‐6.12) and birth weight < 2500 grams (1.81; 1.07‐3.06). Breast infants who also received solid food during their first six months of life were significantly more likely to acquire infection than were exclusively breastfed children (HR 10;87; 1.51‐78.00; p=0.018), as were infants who at 12 weeks received both breast milk and formula milk (1.82; 0.98‐3.36; p=0.057). Mortality: Cumulative 3‐month mortality was15.1% (7.63‐28.73) in infants given replacement feeds vs. 6.1% (4.74‐7.92) among exclusively breastfed infants (HR 2.06; 1.00‐4.27, p=0.51). |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | High risk | Not a randomized controlled trial |
| Allocation concealment? | High risk | Not a randomized controlled trial |
| Blinding? All outcomes | High risk | This study was not blinded. |
| Incomplete outcome data addressed? All outcomes | Low risk | "Data for nevirapine uptake and ingestion were inconsistent and are not included in any analysis." |
| Free of selective reporting? | Low risk | No problems apparent |
| Free of other bias? | Low risk | No problems apparent |