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

March 8, 2017 updated by: Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Domperidone maleate
domperidone maleate tablet 10 mg orally three times daily for 14 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: Domperidone maleate
domperidone maleate tablet 10 mg orally three times daily for 28 days
Drug: Domperidone maleate
domperidone maleate tablet 10 mg orally three times daily for 14 days
Drug: Placebo Tablet
placebo tablet 10 mg orally three times daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 0 to day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 0 to 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
Day 0 and day 14
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
day 0 and 28
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
days 0 and 14
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
day 15 and day 28
Provision of Breast Milk at Term Gestation
Time Frame: term gestation
provision of breast milk as the primary source of nutrition
term gestation
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
6 weeks post term gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 232-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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