Abstract
BACKGROUND: Using mother’s own expressed breast milk (EBM) has a positive impact in reducing serious neonatal morbidities and improving neurodevelopmental outcomes for very preterm infants. Mothers often struggle to maintain a supply of EBM during prolonged hospitalization. In small studies, domperidone, a potent dopamine D2 receptor antagonist that stimulates the release of prolactin, has been shown to enhance EBM production.
OBJECTIVES: The primary objective was to determine whether administration of domperidone, within the first 21 days after delivery, would lead to a higher proportion of mothers having a 50% increase in the volume of EBM at the end of 14 days of treatment. The secondary objectives were to determine if a 28 day compared to a 14 day treatment yielded a higher proportion of mothers with a 50% increase in EBM volumes; and 2) to determine if a later initiation of domperidone differed in obtaining a 50% increase in EBM volume.
DESIGN/METHODS: EMPOWER was a multicenter, double masked, randomized controlled phase-II trial. Eligible mothers were randomized to one of two treatment arms: group A: domperidone 10 mg orally three times daily for 28 days; group B: identical 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 were randomized equally into the 2 arms; 82 were included in the analysis of the primary outcome. Baseline characteristics were similar between the two groups of mothers. There was a significant difference in the proportion of mothers who achieved a 50% increase in EBM volume at the end of the first 14 days of the study treatment: 77.8% in group A vs. 57.8% in group B [OR 0.39, 95% CI 0.16, 0.98, p=0.04] However, there was no difference in the proportion of mothers who achieved a 50% increase in EBM volume on day 28: 68.9% in group A vs. 66.7% in group B [OR .90, 95% CI 0.37, 2.19].
CONCLUSION: Introducing a galactogogue may be helpful in aiding mothers of preterm infants who present with an insufficient supply of EBM within the first 21 to 35 days after birth.