Elizabeth V Asztalos1, Alex Kiss2, Orlando P daSilva3, Marsha Campbell-Yeo4, Shinya Ito5, David Knoppert6. 1. 1 Department of Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada. 2. 2 Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada. 3. 3 Perinatal and Women's Health, London Health Sciences Centre, Western University, London, Canada. 4. 4 Izaak Walton Killam Health Centre, Dalhousie University, Halifax, Canada. 5. 5 Division of Clinical Pharmacology & Toxicology, Department of Paediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada. 6. 6 School of Pharmacy, University of Waterloo, Waterloo, Canada.
Abstract
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 receiveddomperidone 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.
RCT Entities:
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.
Entities:
Keywords:
breast milk production; domperidone; mothers of preterm infants
Authors: Elizabeth V Asztalos; Alex Kiss; Orlando P daSilva; Marsha Campbell-Yeo; Shinya Ito; David Knoppert Journal: Int Breastfeed J Date: 2019-06-04 Impact factor: 3.461