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Morbidity and Mortality in Breastfed and Formula-Fed Infants of HIV-1–Infected Women
A Randomized Clinical Trial
Dorothy Mbori-Ngacha, MBChB,MPH;
Ruth Nduati, MBChB,MPH;
Grace John, MD,PhD;
Marie Reilly, PhD;
Barbra Richardson, PhD;
Anthony Mwatha, MS;
Jeckoniah Ndinya-Achola, MBChB;
Job Bwayo, PhD;
Joan Kreiss, MD,MSPH
JAMA. 2001;286:2413-2420.
Context Breastfeeding among women infected with human immunodeficiency virus type 1 (HIV-1) is associated with substantial risk of HIV-1 transmission, but little is known about the morbidity risks associated with formula feeding in infants of HIV-1–infected women in resource-poor settings.
Objective To compare morbidity, nutritional status, mortality adjusted for HIV-1 status, and cause of death among formula-fed and breastfed infants of HIV-1–infected women.
Design Randomized clinical trial conducted between 1992 and 1998.
Setting Four antenatal clinics in Nairobi, Kenya.
Participants Of 401 live-born, singleton, or first-born twin infants of randomized HIV-1–seropositive mothers, 371 were included in the analysis of morbidity and mortality.
Interventions Mothers were randomly assigned either to use formula (n = 186) or to breastfeed (n = 185) their infants.
Main Outcome Measures Mortality rates, adjusted for HIV-1 infection status; morbidity; and nutritional status during the first 2 years of life.
Results Two-year estimated mortality rates among infants were similar in the formula-feeding and breastfeeding arms (20.0% vs 24.4%; hazard ratio [HR], 0.8; 95% confidence interval [CI], 0.5-1.3), even after adjusting for HIV-1 infection status (HR, 1.1; 95% CI, 0.7-1.7). Infection with HIV-1 was associated with a 9.0-fold increased mortality risk (95% CI, 5.3-15.3). The incidence of diarrhea during the 2 years of follow-up was similar in formula and breastfeeding arms (155 vs 149 per 100 person-years, respectively). The incidence of pneumonia was identical in the 2 groups (62 per 100 person-years), and there were no significant differences in incidence of other recorded illnesses. Infants in the breastfeeding arm tended to have better nutritional status, significantly so during the first 6 months of life.
Conclusions In this randomized clinical trial, infants assigned to be formula fed or breastfed had similar mortality rates and incidence of diarrhea and pneumonia during the first 2 years of life. However, HIV-1–free survival at 2 years was significantly higher in the formula arm. With appropriate education and access to clean water, formula feeding can be a safe alternative to breastfeeding for infants of HIV-1–infected mothers in a resource-poor setting.
Author Affiliations: Departments of Paediatrics (Drs Mbori-Ngacha and Nduati) and Medical Microbiology (Dr Bwayo and Mr Mwatha), University of Nairobi, Nairobi, Kenya; the Departments of Medicine (Drs John and Kreiss), Epidemiology (Dr Kreiss), and Biostatistics (Dr Richardson), University of Washington, Seattle (Drs John, Richardson, and Kreiss); and the Department of Epidemiology and Public Health, University College, Cork, Ireland (Dr Reilly).
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