NCT00308334

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

A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Low Breast Milk Supply

Interventions

Type	Name	Description
DRUG	Domperidone	10 mg po TID X 14 days
DRUG	Placebo- Sugar pill	placebo po TID x 14 days

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-12-01
• Completion: 2008-01-01
• First posted: 2006-03-29
• Last updated: 2009-06-11

Locations

1 site across 1 country: Canada