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

IWK Health Centre

Status and phase

Completed

Phase 3

Phase 2

Conditions

Low Breast Milk Supply

Treatments

Drug: Placebo- Sugar pill

Drug: Domperidone

Study type

Interventional

Funder types

Other

Identifiers

NCT00308334

2498

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

Female

Volunteers

No Healthy Volunteers

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