A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- IWK Health Centre
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- The protein levels from breast milk will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days).
Study Overview
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 women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Domperidone
Domperidone
Intervention: Domperidone (Drug)
placeob- Sugar pill
Intervention: Placebo- Sugar pill (Drug)
Outcomes
Primary Outcomes
The protein levels from breast milk will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days).
Time Frame: days 0, 4, 7, and 14
Secondary Outcomes
- infant weights(daily X 14 days)
- Serum prolactin level(Day 0, 4 and 14)
- The fat, carbohydrate, lactose, energy, calcium, phosphorus and sodium content of breast milk will be compared between domperidone and placebo groups.(days 0, 4, 7, and 14,)
- Breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights)(Daily X 14 days)
- breastfeeding rates(two weeks after treatment completion and at discharge)