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Breastfeeding and Breast Milk: Clinical Trials

The NICHD conducts and supports a variety of clinical research projects related to breastfeeding. Select a link below to learn more about these projects.

Featured NICHD Clinical Trials on Breastfeeding

  • Effects of Tenofovir HIV Medication on Bone Health and Kidneys during Pregnancy and Breastfeedinghttp://clinicaltrials.gov/ct2/show/NCT01066858
    NICHD-funded researchers are examining the effects of tenofovir, which is an HIV Treatment Medication, in women who use the medication during pregnancy and/or breastfeeding. Some adults (who are not pregnant) and children who take anti-HIV medications develop problems with their kidneys and bone strength. This study will examine whether women who are pregnant or breastfeeding develop similar problems. The study is part of a larger study being conducted by the International Maternal, Pediatric, Adolescent AIDS Clinical Trials Group, which is evaluating the safety of anti-HIV medications used in pregnancy and during breastfeeding.
  • Neurodevelopmental Outcomes of Donor Milk in Very Low Birth Weight (VLBW) Infantshttp://clinicaltrials.gov/ct2/show/NCT01232725
    This study is examining whether donor milk is associated with better neurodevelopmental outcomes in VLBW infants compared with feeding them preterm infant formula. Breastfeeding is an important health-promoting behavior. However, breast milk, either from the mother or pumped breast milk, is not always available. VLBW infants are breastfed at some of the lowest rates in the U.S., but are at a high risk for life-long disabilities, including neurodevelopmental delays. The study will examine whether breast milk fed to infants from birth conveys improvements over formula feeding alone in infants evaluated at 18 to 22 months.
  • Effects of Protein Calorie Supplementation (PCS) in Women with HIV Who Are Breastfeeding http://clinicaltrials.gov/ct2/show/NCT01461863
    NICHD-funded researchers are examining whether PCS of the food of women who have HIV is beneficial to health outcomes and immunity. In many resource-poor countries where HIV is endemic, such as in sub-Saharan Africa, nutrition plays a critical role in the health of women who are infected with HIV. In addition, nutrition also affects the risk of tuberculosis (TB). Women who are infected with HIV and who are also breastfeeding and their infants are at a higher risk for poor health if they do not receive adequate nutrition. This study is examining the effect of PCS on several health measures in women who have HIV and are breastfeeding. These measures include, among others, whether PCS in breastfeeding women decreases HIV viral load, enhances passively transferred immune factors in breast milk, improves TB-specific immunity, and improves outcomes in women with HIV and active TB.
  • Impact of Dietary Supplements on the Intestinal Microflora of Premature Infantshttp://clinicaltrials.gov/ct2/show/NCT00810160
    In research funded by the NICHD, researchers are examining whether supplementing the formula of infants with a dietary supplement to promote fecal microflora (beneficial microbes in the intestines) changes their intestinal microflora content. The researchers are seeking to determine the optimum dietary dose to promote fecal microflora in formula-fed premature infants that is similar to that of term breastfed infants, who have a predominance of bifidobacteria. The results of this study can be applied to later trials to examine the benefit of dietary supplementation on health measures, including intestinal health and other outcomes.
  • Promotion of Breastfeeding Intervention Trial (PROBIT)
    http://clinicaltrials.gov/ct2/show/NCT01561612
    The PROBIT study, which was supported by the NICHD and is now complete, examined the influence of a randomized breastfeeding promotion intervention that was designed to increase the duration and exclusivity of breastfeeding on the development of maternal and child health outcomes. Primary outcome measures in infants included infant growth to 12 months of age, gastrointestinal tract and respiratory tract infections, and occurrence of atopic eczema. The study also examined maternal and child adiposity and other health measures in children who were breastfed as infants, including, among others, asthma, cognition, dental caries, vision, lung function, and behavior.

NICHD Clinical Trials

ClinicalTrials.gov Search Results

Information on current NIH-sponsored clinical trials on breastfeeding is available at the link below or by calling 800-411-1222.

Last Updated Date: 11/30/2012
Last Reviewed Date: 11/30/2012
Vision National Institutes of Health Home BOND National Institues of Health Home Home Storz Lab: Section on Environmental Gene Regulation Home Machner Lab: Unit on Microbial Pathogenesis Home Division of Epidemiology Statistics and Prevention Branch Home Bonifacino Lab: Section on Intracellular Protein Trafficking Home Lilly Lab: Section on Gamete Development Home Lippincott-Schwartz Lab: Section on Organelle Biology