Clinical trial NCT01512225: Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates
Official title: Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Milk Supply
Keywords: breastmilk
domperidone
preterm
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Domperidone in those mothers who are identified as having difficulty with breast milk production to meet the nutritional needs of their infant in the neonatal intensive are unit hospitalization setting, and to determine how it should be considered in the care of mothers and their preterm infants without causing undesirable effects to either the mother or infant.

Detailed description: It is widely acknowledged that recent perinatal and neonatal technological advances (eg. assisted ventilation, surfactant, antenatal corticosteroids) have greatly enhanced the survival rate of very low birth weight and extremely low birth weight infants. A compelling body of evidence now exists to suggest that use of breast milk to feed preterm infants during initial hospitalization positively impacts their neurodevelopment during early childhood and beyond. In order to provide breastmilk, mothers of preterm infants have to begin to produce and mechanically express milk. However, these mothers are often faced with challenges in maintaining an adequate volume that will meet their infants' nutritional needs, as well as declines in production after several weeks despite a myriad of measures designed to assist in production. The primary hypothesis for this study is that Domperidone, through its pharmacologic action on increasing prolactin levels, will assist mothers experiencing inadequate breast milk production in increasing breast milk volumes to a level identified as being sufficient for continued pumping in the hospitalization period.

Eligibility criteria: Inclusion Criteria:

* mothers of a preterm infant born \< 30 completed weeks gestation (23 0/7-29 6/7 weeks)
* postpartum period of 7-21 days
* mechanically pumping a minimum average of 6 times a day in the 4-7 days prior to enrollment
* experiencing inadequate milk supply defined as providing \< 100% of the average of the daily nutritional intake during the previous 72-hour period prior to enrollment based on a fluid intake of 250 mL/kg/d or experiencing a clinical reduction of approximately 20% from a peak volume during the previous 72-hour period prior to enrollment

Exclusion Criteria:

* history of known or suspected cardiac dysrhythmias (tachyarrhythmia, Q-Tc prolongation) or currently on an anti-arrhythmic medication
* currently experiencing mastitis
* previous breast surgery, including augmentation or reduction, nipple piercing and/or the use of nipple rings/studs within the last year, or any reduction
* known chronic or debilitating illness, known abnormal liver function or gastric abnormalities gastrointestinal that will be exacerbated by the use of a prokinetic, examples include hemorrhage or blockage, actively treated with acid reflux which requires treatment for greater than 5 days and includes H2 blockers (occasional use of H2 blockers for heartburn or mild acid reflux is not considered an exclusion) and HIV
* known to have a prolactin-releasing pituitary tumor
* receiving medications known to alter the metabolism and pharmacokinetics of domperidone (eg. oral "azole" antifungals, erythromycin antibiotics, monoamine oxidase inhibitors (MAO) inhibitors) or medications that have dopaminergic or antidopaminergic activity or affect prolactin levels
* mothers of higher order pregnancies (triplet, or more)
* currently smoking 6 or more cigarette per day as reported by the mother

Primary outcomes:
measure: Increase in Breast Milk Production
timeFrame: Day 0 to day 14
Secondary outcomes:
measure: Increase in Breast Milk Volume on Day 28
timeFrame: day 0 to day 28
measure: Mean Breast Milk Volumes on Day 14
timeFrame: Day 0 and day 14
measure: Mean Breast Milk Volumes on Day 28
timeFrame: day 0 and 28
measure: Mean Volume Change From Day 0 to Day 14
timeFrame: days 0 and 14
measure: Mean Volume Change on the Volume of Milk From Day 15 to Day 28
timeFrame: day 15 and day 28
measure: Provision of Breast Milk at Term Gestation
timeFrame: term gestation
measure: Provision of Breast Milk at 6 Weeks Post Term Gestation
timeFrame: 6 weeks post term gestation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Elizabeth V Asztalos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IWK Health Centre
name: Marsha Campbell-Yeo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital, London Health Sciences Centre
name: Orlando Da Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asztalos EV, Campbell-Yeo M, da Silva OP, Ito S, Kiss A, Knoppert D; EMPOWER Study Collaborative Group. Enhancing Human Milk Production With Domperidone in Mothers of Preterm Infants. J Hum Lact. 2017 Feb;33(1):181-187. doi: 10.1177/0890334416680176. Epub 2017 Jan 20.
citation: Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Role of days postdelivery on breast milk production: a secondary analysis from the EMPOWER trial. Int Breastfeed J. 2019 Jun 4;14:21. doi: 10.1186/s13006-019-0215-z. eCollection 2019.
citation: Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; <italic>EMPOWER</italic> Study Collaborative Group. Evaluating the Effect of a 14-Day Course of Domperidone on Breast Milk Production: A Per-Protocol Analysis from the EMPOWER Trial. Breastfeed Med. 2019 Mar;14(2):102-107. doi: 10.1089/bfm.2018.0175. Epub 2018 Dec 13.
citation: Asztalos EV, Kiss A, da Silva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Pregnancy gestation at delivery and breast milk production: a secondary analysis from the EMPOWER trial. Matern Health Neonatol Perinatol. 2018 Nov 5;4:21. doi: 10.1186/s40748-018-0089-x. eCollection 2018.
citation: Asztalos EV, Campbell-Yeo M, daSilva OP, Kiss A, Knoppert DC, Ito S. Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial). BMC Pregnancy Childbirth. 2012 Aug 31;12:87. doi: 10.1186/1471-2393-12-87.