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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01512225
First received: January 10, 2012
Last updated: March 14, 2014
Last verified: March 2014
  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 (NICU) 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: Domperidone maleate plus placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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: 14 days ] [ Designated as safety issue: No ]
    The primary outcome is the difference between the two groups in achieving a 50% increase in breast milk volume at the end of the first 2-week period (mean day 14 volume minus mean day 0 volume at entry).


Secondary Outcome Measures:
  • Difference in volume of breast milk [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Mean difference in the tabulated volume in breast milk recorded between the two groups at 2 and 4 weeks (mean day 14 or 28 volume minus mean day 0 volume at entry)

  • Mean difference in milk supply [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Mean within-subject differences in milk supply between the two groups at 2 and 4 weeks (mean day 14 or 28 volume minus mean day 0 volume at entry)

  • Gestational age effect [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Effect of gestational age at the time of delivery on the volume of milk (23-26 and 27-29 weeks gestation at delivery) between the two groups

  • Timing of inadequate milk supply [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Effect of timing of inadequate milk supply post delivery on the volume of milk (7-14 and 15-21 days) between the two groups

  • Difference in supplementation [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Difference in the use of supplementation to expressed breast milk, such as formula or donor breast milk between the two groups during the study period (day 14 and 28)

  • Rates of breastfeeding [ Time Frame: up to 6 weeks post term ] [ Designated as safety issue: No ]
    Rates of breastfeeding, use of supplementation, such as formula or donor breast milk at 40 weeks post conceptual age (term) and at 6 weeks post term between the different groups

  • Difference in adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Potential differences in adverse events, in particular, those related to gastrointestinal or cardiac difficulties


Estimated Enrollment: 560
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Domperidone
Domperidone 10 mg orally three times daily for 28 days
Drug: Domperidone maleate
domperidone 10 mg orally three times daily for 28 days
Active Comparator: Domperidone plus placebo
Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Drug: Domperidone maleate plus placebo
identical placebo 10 mg orally three times daily for 14 days followed by domperidone 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 (VLBW) and extremely low birth weight (ELBW) 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
Genders 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

Contacts
Contact: Melissa Brown, BS 416-480-5654 empower@sunnybrook.ca
Contact: J. Michelle Filice, BPHE 416-480-5639 michelle.filice@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
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

No publications provided by Sunnybrook Health Sciences Centre

Additional 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
Last Updated: March 14, 2014
Health Authority: Canada: Health Canada
Canada: Canadian Institutes of Health Research

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014