Official Title: “A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk”

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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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.

Intervention(s) in this Clinical Trial

• Drug: domperidone orally (10 mg x 3/daily)

Primary Measures

• The protein levels from breast milk, collected on days 0, 4, 7, and 14 will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days).

Secondary Measures

• The fat, carbohydrate, lactose, energy, calcium, phosphorus and sodium content of breast milk, collected on days 0, 4, 7, and 14, will be compared between domperidone and placebo groups.
• Other outcomes
• Daily breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights)
• serum prolactin level
• daily infant weights
• breastfeeding rates two weeks after treatment completion and at discharge

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: IWK Health Centre

Overall Clinical Trial Officials and Contacts

Marsha L Campbell-Yeo, RN, MN, NNP Principal Investigator IWK Health Centre  

Overall Contact: Marsha l Campbell-Yeo, RN MN NNP 902 470-8895 marsha.campbellyeo@iwk.nshealth.ca

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00308334

Study ID Number: 2498

ClinicalTrials.gov Identifier: NCT00308334

Health Authority: Canada: Health Canada