Status:
COMPLETED
Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk
Lead Sponsor:
IWK Health Centre
Collaborating Sponsors:
Canadian Nurses Foundation (CNF)
Dalhousie University
Conditions:
Low Breast Milk Supply
Eligibility:
FEMALE
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.
Detailed Description
Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating wome...
Eligibility Criteria
Inclusion
- i. Mother of an infant born less than 31 weeks gestation
- ii. Women mechanically expressing breast milk using a double collecting system
- iii. Experiencing lactation failure indicated by at least one of the following: A decreasing milk supply (by greater than 30 percent from peak volume based on maternal account) An inability to provide adequate breast milk to meet the daily nutritional intake of their infant
- iv. Women who have had little or no improvement in milk production following education/counseling with a lactation consultant/Neonatal Intensive Care nurse with respect to non-pharmacological techniques.
- v. Postpartum period equal to or greater than three weeks.
Exclusion
- i. Participants receiving any medication known to alter the effect of domperidone (e.g.cimetidine, ranitidine, famotidine, and nizatidine) or medication that interacts with domperidone (e.g. haloperidol, lithium).
- ii. Experiencing mastitis
- iii. Having a chronic or debilitating illness.
- iv. Previous breast surgery
- v. Having a known lactose intolerance
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00308334
Start Date
October 1 2003
End Date
January 1 2008
Last Update
June 11 2009
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8