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For moms with premature babies, domperidone is just one consideration

Feb 14, 2017

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A study looking at giving domperidone, a drug with the side effect of stimulating milk production in lactating women, to mothers with preterm babies was found to increase milk volume in this high-risk group. At the same time, the EMPOWER Trial suggests mothers with infants in a neonatal intensive care unit (NICU) require greater support and education to ensure their babies continue to receive human milk.

The EMPOWER Trial was a randomized controlled trial involving 90 mothers, with babies born at 29 weeks or earlier, at eight level 3 neonatal intensive care centres across Canada. The first group of mothers received 10 mg of domperidone, taken three times a day for 28 days. The second group received a placebo for 14 days, followed by 10 mg of domperidone taken three times a day for 14 days. Doses followed Health Canada’s 2015 guidelines recommending that domperidone should be used at the lowest effective dose, to a maximum recommended daily dose of 30 mg, for the shortest possible duration.

“Mother’s milk is precious for babies who are born preterm and has been proven to reduce serious illnesses for these babies,” says Dr. Elizabeth Asztalos, neonatologist at Sunnybrook Health Sciences Centre and principal investigator of the EMPOWER Trial. “By introducing domperidone much earlier in women with a confirmed low-milk supply, we were anxious to see if there was an impact on milk production, and also the impact of having women on the drug for four weeks versus two weeks.”

Domperidone was effective in supporting more women to increase milk volume, starting as early as eight days post-delivery. However, beginning domperidone two weeks later showed a similar impact on milk volume and suggests that one can start domperidone later and still achieve benefit.

“Mothers absolutely do respond, but the response pattern really varies. The mothers in the placebo group were still able to increase their milk supply compared to those taking domperidone but not as many achieved it,” says Dr. Asztalos. “This suggests that mothers with preterm infants need all of the lactation supports in a neonatal setting to help with breast milk production, which includes support to establish an effective pumping schedule. Domperidone alone is not a panacea; it is one component in a battery of supports for these mothers.”

Despite the small study sample, study investigators were reassured there were no real differences in side effects in both randomized groups, and no adverse events were reported including serious cardiac events.

“Focusing on improving the early provision of mother’s own milk by introducing lactation support immediately following delivery can make a positive difference,” added Dr. Asztalos. “Having a baby in the NICU is extremely challenging. Mothers need a lot of support and encouragement to achieve milk production and then to maintain it during their infant’s time in the NICU.”