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Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates (EMPOWER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01512225
First received: January 10, 2012
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Low Milk Supply
Drug: Domperidone maleate
Drug: Placebo Tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Increase in Breast Milk Production [ Time Frame: Day 0 to day 14 ]
    The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).


Secondary Outcome Measures:
  • Increase in Breast Milk Volume on Day 28 [ Time Frame: day 0 to day 28 ]
    Number of mothers who achieved 50% increase in milk volume on day 28

  • Mean Breast Milk Volumes on Day 14 [ Time Frame: Day 0 and day 14 ]
    Mean milk volumes between the two groups at 14 days of study intervention

  • Mean Breast Milk Volumes on Day 28 [ Time Frame: day 0 and 28 ]
    Mean milk volumes between the two groups at 28 days of study intervention

  • Mean Volume Change From Day 0 to Day 14 [ Time Frame: days 0 and 14 ]
    change on the volume of milk from day 0 to day 14 between the two groups

  • Mean Volume Change on the Volume of Milk From Day 15 to Day 28 [ Time Frame: day 15 and day 28 ]
    change on the volume of milk from day 15 to day 28 between the two groups

  • Provision of Breast Milk at Term Gestation [ Time Frame: term gestation ]
    provision of breast milk as the primary source of nutrition

  • Provision of Breast Milk at 6 Weeks Post Term Gestation [ Time Frame: 6 weeks post term gestation ]
    Provision of breast milk at 6 weeks post term gestation as primary source of nutrition


Enrollment: 90
Study Start Date: May 2012
Study Completion Date: March 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Domperidone for days 1 to 28
Domperidone maleate tablets 10 mg orally three times daily from days 1 to 28
Drug: Domperidone maleate
domperidone maleate tablet 10 mg orally three times daily for 28 days
Placebo Comparator: Placebo for days 1 to 14 and domperidone for day 15-28
Identical placebo tablets 10 mg orally three times daily from days 1 to 14 followed by Domperidone maleate tablets 10 mg orally three times daily from days 15 to 28
Drug: Placebo Tablet
placebo tablet 10 mg orally three times daily for 14 days
Drug: Domperidone maleate
domperidone maleate tablet 10 mg orally three times daily for 14 days

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512225

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Elizabeth V Asztalos, MD Sunnybrook Research Institute
Principal Investigator: Marsha Campbell-Yeo, PhD IWK Health Centre
Principal Investigator: Orlando Da Silva, MD Children's Hospital London Health Sciences Centre
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01512225     History of Changes
Other Study ID Numbers: 232-2011
Study First Received: January 10, 2012
Results First Received: November 7, 2016
Last Updated: March 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Sunnybrook Health Sciences Centre:
breastmilk
domperidone
preterm

Additional relevant MeSH terms:
Domperidone
Maleic acid
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2017