Role of days postdelivery on breast milk production: a secondary analysis from the EMPOWER trial.

Background: With an increasing demand for mother's own milk to be viewed as a primary source of nutritional support in the care of very small and preterm infants, mothers of preterm infants may be at risk of expressing suboptimal amounts of milk. The use of a galactogogue is often considered when these mothers are still having challenges in breast milk production. Methods: For this analysis, the study participants were the 90 mothers who participated in the EMPOWER trial and, at the time of randomization, were stratified by days post-delivery, 8-14 days and 15-21 days. The primary outcome measure was the proportion of mothers in each of the days post-delivery groups who achieved a 50% increase in breast milk volume on day 14 of the study treatment period. Results: There was no significant difference in the proportion of mothers in the 8-14 days group (75.0%) who achieved a 50% increase in breast milk volume on day 14 of the study treatment period.compared to those in the 15-21 days group (60.9%), OR 1.93 (95% CI 0.78, 4.76; p = 0.15). Because comorbidities and exposure to antenatal corticosteroids between the groups of mothers were viewed as potential confounders, a logistic regression was performed after controlling for these two variables with the adjusted OR being 1.84 (0.73, 4.64; p = 0.19). Conclusions: This secondary analysis was able to demonstrate that mothers of very preterm infants, < 30 weeks gestation at birth, were able to respond to the study treatment in a similar fashion regardless of timing of entry and exposure to domperidone. In the presence of a suboptimal breast milk production by the end of the first week postpartum, below 250 ml/kg/d based on infant birth weight, a 14 day treatment of domperidone could be considered to augment breast milk production. Trial registration: EMPOWER has been registered at http://www.clinicaltrials.gov (identifier NCT01512225) on January 10, 2012.

Evaluating the Effect of a 14-Day Course of Domperidone on Breast Milk Production: A Per-Protocol Analysis from the EMPOWER Trial.

BACKGROUND: Galactogogues are often considered when mothers of very preterm infants experience challenges in producing adequate amounts of breast milk. We conducted a per-protocol analysis of those mothers who completed a 14-day course of domperidone during the EMPOWER trial. Our primary aim was to evaluate the response to a completed course of domperidone and whether the response was affected by the timing of the initiation of intervention. METHODS: For this analysis, 83 mothers of infants ≤29 weeks gestation were included: 45 mothers who received domperidone from days 1 to 14 of the trial study treatment period and 38 mothers who received domperidone from days 15 to 28. Domperidone was given at a dose of 10 mg thrice daily for 14 days. The primary outcome was the proportion of mothers who achieved a modest 50% increase in breast milk volume from the volume at the end of the 2-week period of treatment of domperidone. RESULTS: When adjusted for the initiation of domperidone treatment, the proportion of mothers in the days 1-14 group (77.8%) was similar compared to those in the days 15-28 group (65.8%), OR 1.96 (95% CI 0.72-5.32; p = 0.19). CONCLUSION: Taking into consideration potential limitations in power, this secondary analysis was able to show that the mothers in the EMPOWER study who were identified as actually completing a 14-day treatment course responded irrespective of the timing of their initiation of domperidone and demonstrated a modest increase in breast milk volume.

The effect of two different domperidone doses on maternal milk production.

BACKGROUND: The benefits of breast milk to the newborn infant are well established. The Canadian Paediatric Society recommends exclusive breastfeeding for the first 6 months of life for healthy, term infants. Mothers of premature newborns, however, may have difficulty providing an adequate supply of breast milk. Domperidone is officially used as a prokinetic agent. However, it is used widely around the world as a galactogogue. Despite its widespread use as a galactogogue, only a small number of investigators have studied domperidone for this indication. AIMS: The purpose of this study was to determine an optimal dosage of domperidone as a galactogogue. METHODS: Eligible subjects were randomized to receive domperidone 10 mg 3 times daily or domperidone 20 mg 3 times daily for 4 weeks. At week 5, the frequency was decreased to twice daily in both groups, and finally once daily for week 6. RESULTS: Over the entire first 4-week period, there was a significant increase in daily milk volumes within each group (P < .01). The between-group difference over this period, although not statistically significant, was clinically significant. Additionally, there was no significant within- or between-group difference during weeks 5 and 6. CONCLUSION: A dose of domperidone of 20 mg, 3 times daily instead of 10 mg, 3 times daily was associated with a clinical, but not statistically significant, increase in milk production.

Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial).

BACKGROUND: The use of mother's own breast milk during initial hospitalization has a positive impact not only in reducing potential serious neonatal morbidities but also contribute to improvements in neurodevelopmental outcomes. Mothers of very preterm infants struggle to maintain a supply of breast milk during their infants' prolonged hospitalization. Galactogogues are medications that induce lactation by exerting its effects through oxytocin or prolactin enhancement. Domperidone is a potent dopamine D2 receptor antagonist which stimulates the release of prolactin. Small trials have established its ability in enhancing breast milk production. EMPOWER was designed to determine the safety and efficacy of domperidone in mothers experiencing an inadequate milk supply. METHODS/DESIGN: EMPOWER is a multicenter, double masked, randomized controlled phase-II trial to evaluate the safety and effectiveness of domperidone in those mothers identified as having difficulty in breast milk production. Eligible mothers will be randomized to one of two allocated groups: Group A: domperidone 10 mg orally three times daily for 28 days; and 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. The primary outcome will be determined at the completion of the first 2-week period; the second 2-week period will facilitate answering the secondary questions regarding timing and duration of treatment. To detect an estimated 30% change between the two groups (from 40% to 28%, corresponding to an odds ratio of 0.6), a total sample size of 488 mothers would be required at 80% power and alpha=0.05. To account for a 15% dropout, this number is increased to 560 (280 per group). The duration of the trial is expected to be 36-40 months. DISCUSSION: The use of a galactogogue often becomes the measure of choice for mothers in the presence of insufficient breast milk production, particularly when the other techniques are unsuccessful. EMPOWER is designed to provide valuable information in guiding the practices for this high-risk group of infants and mothers. The results of this trial will also inform both mothers and clinicians about the choices available to increase and maintain sufficient breast milk. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01512225.