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

Primary Purpose

Low Milk Supply

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Domperidone maleate

Placebo Tablet

Domperidone maleate

About this trial

This is an interventional treatment trial for Low Milk Supply focused on measuring breastmilk, domperidone, preterm

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Domperidone for days 1 to 28

Placebo for days 1 to 14 and domperidone for day 15-28

Arm Description

Domperidone maleate tablets 10 mg orally three times daily from days 1 to 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

Outcomes

Primary Outcome Measures

Increase in Breast Milk Production

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

Number of mothers who achieved 50% increase in milk volume on day 28

Mean Breast Milk Volumes on Day 14

Mean milk volumes between the two groups at 14 days of study intervention

Mean Breast Milk Volumes on Day 28

Mean milk volumes between the two groups at 28 days of study intervention

Mean Volume Change From Day 0 to Day 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

change on the volume of milk from day 15 to day 28 between the two groups

Provision of Breast Milk at Term Gestation

provision of breast milk as the primary source of nutrition

Provision of Breast Milk at 6 Weeks Post Term Gestation

Provision of breast milk at 6 weeks post term gestation as primary source of nutrition

Full Information

NCT ID

NCT01512225

First Posted

January 10, 2012

Last Updated

March 8, 2017

Sponsor

Sunnybrook Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT01512225

Brief Title

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Acronym

EMPOWER

Official Title

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Milk Supply

Keywords

breastmilk, domperidone, preterm

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Domperidone for days 1 to 28

Arm Type

Experimental

Arm Description

Domperidone maleate tablets 10 mg orally three times daily from days 1 to 28

Arm Title

Placebo for days 1 to 14 and domperidone for day 15-28

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Domperidone maleate

Intervention Description

domperidone maleate tablet 10 mg orally three times daily for 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo Tablet

Intervention Description

placebo tablet 10 mg orally three times daily for 14 days

Intervention Type

Drug

Intervention Name(s)

Domperidone maleate

Intervention Description

domperidone maleate tablet 10 mg orally three times daily for 14 days

Primary Outcome Measure Information:

Title

Increase in Breast Milk Production

Description

Time Frame

Day 0 to day 14

Secondary Outcome Measure Information:

Title

Increase in Breast Milk Volume on Day 28

Description

Number of mothers who achieved 50% increase in milk volume on day 28

Time Frame

day 0 to day 28

Title

Mean Breast Milk Volumes on Day 14

Description

Mean milk volumes between the two groups at 14 days of study intervention

Time Frame

Day 0 and day 14

Title

Mean Breast Milk Volumes on Day 28

Description

Mean milk volumes between the two groups at 28 days of study intervention

Time Frame

day 0 and 28

Title

Mean Volume Change From Day 0 to Day 14

Description

change on the volume of milk from day 0 to day 14 between the two groups

Time Frame

days 0 and 14

Title

Mean Volume Change on the Volume of Milk From Day 15 to Day 28

Description

change on the volume of milk from day 15 to day 28 between the two groups

Time Frame

day 15 and day 28

Title

Provision of Breast Milk at Term Gestation

Description

provision of breast milk as the primary source of nutrition

Time Frame

term gestation

Title

Provision of Breast Milk at 6 Weeks Post Term Gestation

Description

Provision of breast milk at 6 weeks post term gestation as primary source of nutrition

Time Frame

6 weeks post term gestation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth V Asztalos, MD

Organizational Affiliation

Sunnybrook Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marsha Campbell-Yeo, PhD

Organizational Affiliation

IWK Health Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Orlando Da Silva, MD

Organizational Affiliation

Children's Hospital, London Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28107101

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.

Results Reference

result

PubMed Identifier

31171928

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.

Results Reference

derived

PubMed Identifier

30543461

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.

Results Reference

derived

PubMed Identifier

30410781

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.

Results Reference

derived

PubMed Identifier

22935052

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.

Results Reference

derived

Learn more about this trial

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

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