Effect of Breastfeeding on Mortality Among HIV-1 Infected Women: A Randomised Trial

Nduati, Ruth; Richardson, Barbra A.; John, Grace C.; Mbori‐Ngacha, Dorothy; Mwatha, Anthony; Ndinya‐Achola, Jeckoniah; Bwayo, Job; Onyango, Francis; Kreiss, Joan K.

doi:10.1097/00006254-200111000-00009

Cited by 57 publications

(65 citation statements)

References 12 publications

(16 reference statements)

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“…Evaluation of the effectiveness of the nutritional supplement for preventing maternal depletion will be based on weight loss between 4 and 28 weeks post-partum. For this outcome we anticipate that mothers not receiving a supplement will lose 0.17 kg/month and mothers receiving a supplement will lose 0 kg/month with a constant standard deviation 1.32 (32). The study sample size as calculated above has over 90% power to detect a difference of 0.20 kg in mean maternal weight loss from 4 to 28 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…Producing breast milk of adequate quantity and quality is, however, nutritionally demanding for mothers, particularly for those who have chronic infections. Unless diet during pregnancy and lactation is adequate, prolonged breastfeeding is likely to lead to maternal nutritional depletion (inadequate nutritional intake compared to metabolic needs) (29–32). Depletion leading to rapid weight loss may place HIV-infected mothers at greater risk of succumbing to opportunistic infections, indirectly increasing their disease progression and risk of death (32;33).…”

Section: Introductionmentioning

confidence: 99%

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Modifications of a large HIV prevention clinical trial to fit changing realities: A case study of the Breastfeeding, Antiretroviral, and Nutrition (BAN) protocol in Lilongwe, Malawi

Horst

Chasela²,

Ahmed

et al. 2009

Contemporary Clinical Trials

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In order to evaluate strategies to reduce HIV transmission through breast milk and optimize both maternal and infant health among HIV-infected women and their infants, we designed and implemented a large, randomized clinical trial in Lilongwe, Malawi. The development of protocols for large, randomized clinical trials is a complicated and lengthy process often requiring alterations to the original research design. Many factors lead to delays and changes, including study site-specific priorities, new scientific information becoming available, the involvement of national and international human subject committees and monitoring boards, and alterations in medical practice and guidance at local, national, and international levels. When planning and implementing a clinical study in a resource-limited setting, additional factors must be taken into account, including local customs and program needs, language and socio-cultural barriers, high background rates of malnutrition and endemic diseases, extreme poverty, lack of personnel, and limited infrastructure. Investigators must be prepared to modify the protocol as necessary in order to ensure participant safety and successful implementation of study procedures. This paper describes the process of designing, implementing, and subsequently modifying the Breastfeeding, Antiretrovirals, and Nutrition, (BAN) study, a large, ongoing, randomized breastfeeding intervention trial of HIVinfected women and their infants conducted at a single site in Lilongwe, Malawi. We highlight some of the successes, challenges, and lessons learned at different stages during the conduct of the trial.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Modifications of a large HIV prevention clinical trial to fit changing realities: A case study of the Breastfeeding, Antiretroviral, and Nutrition (BAN) protocol in Lilongwe, Malawi

Horst

Chasela²,

Ahmed

et al. 2009

Contemporary Clinical Trials

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show abstract

“…HIV/AIDS was the leading cause of maternal mortality in the South African Confidential Enquiry into Maternal Deaths in 2000 22. A recent study from Kenya found that mortality among HIV-1 infected mothers was higher in women who breast fed than in women who fed their babies with formula (18 v 6 deaths; log rank test P=0.009) 23. In this study, maternal death was associated with an increased risk of subsequent infant death, and, even after controlling for HIV-1 infection in the infant, it was shown that infants of mothers who died had an eightfold increase in the likelihood of subsequent death.…”

Section: Effect Of Hiv Related Maternal Mortality On Infant Survivalmentioning

confidence: 97%

What can we do to reduce mother to child transmission of HIV?

McIntyre

Gray²

2002

BMJ

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“…It is unclear how seriously these demands affect their own health. Two studies found that weight loss in HIV-infected mothers during lactation led to higher mortality among these women (15,16), whereas 2 other studies found no association of breastfeeding with mortality (17,18).…”

Section: Introductionmentioning

confidence: 98%

Use of Lipid-Based Nutrient Supplements by HIV-Infected Malawian Women during Lactation Has No Effect on Infant Growth from 0 to 24 Weeks

Flax

Bentley

Chasela

et al. 2012

The Journal of Nutrition

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The Breastfeeding, Antiretrovirals, and Nutrition Study evaluated the effect of daily consumption of lipid-based nutrient supplements (LNS) by 2121 lactating, HIV-infected mothers on the growth of their exclusively breast-fed, HIV-uninfected infants from 0 to 24 wk. The study had a 2 × 3 factorial design. Malawian mothers with CD4(+) ≥250 cells/mm(3), hemoglobin ≥70 g/L, and BMI ≥17 kg/m(2) were randomized within 36 h of delivery to receive either no LNS or 140 g/d of LNS to meet lactation energy and protein needs, and mother-infant pairs were assigned to maternal antiretroviral drugs (ARV), infant ARV, or no ARV. Sex-stratified, longitudinal, random effects models were used to estimate the effect of the 6 study arms on infant weight, length, and BMI. Logistic regression models were used to calculate the odds of growth faltering [decline in weight-for-age Z-score (WAZ) or length-for-age Z-score (LAZ) >0.67] using the control arm as the reference. Although some differences between study arms emerged with increasing infant age in boys, there were no consistent effects of the maternal supplement across the 3 growth outcomes in longitudinal models. At the ages where differences were observed, the effects on weight and BMI were quite small (≤200 g and ≤0.4 kg/m(2)) and unlikely to be of clinical importance. Overall, 21 and 34% of infants faltered in WAZ and LAZ, respectively. Maternal supplementation did not reduce the odds of infant weight or length faltering from 0 to 24 wk in any arm. These results indicate that blanket supplementation of HIV-infected lactating women may have little impact on infant growth.

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Effect of Breastfeeding on Mortality Among HIV-1 Infected Women: A Randomised Trial

Cited by 57 publications

References 12 publications

Modifications of a large HIV prevention clinical trial to fit changing realities: A case study of the Breastfeeding, Antiretroviral, and Nutrition (BAN) protocol in Lilongwe, Malawi

Modifications of a large HIV prevention clinical trial to fit changing realities: A case study of the Breastfeeding, Antiretroviral, and Nutrition (BAN) protocol in Lilongwe, Malawi

What can we do to reduce mother to child transmission of HIV?

Use of Lipid-Based Nutrient Supplements by HIV-Infected Malawian Women during Lactation Has No Effect on Infant Growth from 0 to 24 Weeks

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