Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2001 Nov 21;286(19):2413-20.
doi: 10.1001/jama.286.19.2413.

Morbidity and mortality in breastfed and formula-fed infants of HIV-1-infected women: A randomized clinical trial

D Mbori-Ngacha  1 , R Nduati, G John, M Reilly, B Richardson, A Mwatha, J Ndinya-Achola, J Bwayo, J Kreiss
Affiliations
Clinical Trial

Morbidity and mortality in breastfed and formula-fed infants of HIV-1-infected women: A randomized clinical trial

D Mbori-Ngacha et al. JAMA. .

Abstract

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trial Flow Diagram of Participants HIV-1 indicates human immunodeficiency virus type 1.
Figure 2
Figure 2
Mortality of Children in the Formula Feeding and Breastfeeding Arms Additional data regarding cumulative mortality are presented in reference 1.
Figure 3
Figure 3
Incidence of Diarrhea by Randomization Arm and Quarter
Figure 4
Figure 4
Mean Weight-for-Height Z Scores by Randomization Arm and Age
See this image and copyright information in PMC

Comment in

References

    1. Nduati R, John G, Mbori-Ngacha DA, et al. Effect of breastfeeding and formula feeding on transmission of HIV-1: A randomized clinical trial. JAMA. 2000;283:1167–1174. - PubMed
    1. De Cock KM, Fowler MG, Mercier E, et al. Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice. JAMA. 2000;283:1175–1182. - PubMed
    1. Jason JM, Nieburg P, Marks JS. Mortality and infectious disease associated with infant-feeding practices in developing countries. Pediatrics. 1984;74(suppl):702–727. - PubMed
    1. WHO Collaborative Study Team on the Role of Breastfeeding on the Prevention of Infant Mortality. Effect of breastfeeding on infant and child mortality due to infectious diseases in less developed countries: a pooled analysis. Lancet. 2000;355:451–455. - PubMed
    1. Feachem RG, Koblinsky MA. Interventions for the control of diarrhoeal diseases among young children: promotion of breast-feeding. Bull World Health Organ. 1984;62:271–291. - PMC - PubMed

Publication types

MeSH terms