Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk

Phase 2

Completed

• Conditions: Low Breast Milk Supply
• Interventions: Drug: Domperidone; Drug: Placebo- Sugar pill

• Registration Number: NCT00308334
• Lead Sponsor: IWK Health Centre

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 Timeline

• Study Start: 2003-10
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-29
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-10
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Domperidone	Domperidone	Domperidone
placeob- Sugar pill	Placebo- Sugar pill	-

Primary Outcome Measures

Name	Time	Method
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).	days 0, 4, 7, and 14

Secondary Outcome Measures

Name	Time	Method
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
Serum prolactin level	Day 0, 4 and 14
infant weights	daily X 14 days
breastfeeding rates	two weeks after treatment completion and at discharge

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada