Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Low Milk Supply Clinical Trial

— EMPOWER  

Official title:

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512225
• Other study ID #: 232-2011
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2012
• Last updated: April 14, 2016
• Start date: May 2012
• Est. completion date: March 2016

Study information

• Verified date: November 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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 (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Milk Supply

Intervention

Drug:
• Domperidone maleate
domperidone 10 mg orally three times daily for 28 days
• 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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in breast milk production	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).	14 days	No
Secondary	Difference in volume of breast milk	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)	28 days	No
Secondary	Mean difference in milk supply	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)	28 days	No
Secondary	Gestational age effect	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	28 days	No
Secondary	Timing of inadequate milk supply	Effect of timing of inadequate milk supply post delivery on the volume of milk (7-14 and 15-21 days) between the two groups	28 days	No
Secondary	Difference in supplementation	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)	28 days	No
Secondary	Rates of breastfeeding	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	up to 6 weeks post term	No
Secondary	Difference in adverse events	Potential differences in adverse events, in particular, those related to gastrointestinal or cardiac difficulties	28 days	Yes