Enhancing Human Milk Production with Domperidone in Mothers of Preterm Infants: Results from the EMPOWER Trial

Abstract

Background: Mothers of preterm infants often are at risk of expressing an inadequate amount of milk for their infants and the use of galactogogues is often considered. Domperidone is a widely used galactogogue with little information available to guide clinicians regarding initiation, timing, and duration of treatment. Research aim: The primary objective of this study was to determine whether administration of domperidone within the first 21 days after delivery would lead to a higher proportion of mothers achieving a 50% increase in the volume of milk at the end of 14 days of treatment compared with mothers receiving placebo. Methods: Eligible mothers were randomized to one of two treatment arms: Group A - domperidone 10 mg orally three times daily for 28 days; or Group B - placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days. Results: A total of 90 mothers of infants ≤ 29 weeks gestation were randomized. Mean milk volumes at entry were similar for both groups. More mothers achieved a 50% increase in milk volume after 14 days in Group A (77.8%) compared with Group B (57.8%), odds ratio = 2.56, 95% confidence interval [1.02, 6.25], p =.04. Conclusion: A greater number of mothers experienced a 50% or more increase in human milk volume, but the absolute increase in milk volume was modest.