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

Sponsor

IWK Health Centre (Other)

Overall Status

Completed

CT.gov ID

NCT00308334

Collaborator

Canadian Nurses Foundation (CNF) (Other), Dalhousie University (Other)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Breast Milk Supply	Drug: Domperidone Drug: Placebo- Sugar pill	Phase 2/Phase 3

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

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Domperidone Domperidone	Drug: Domperidone 10 mg po TID X 14 days
Placebo Comparator: placeob- Sugar pill	Drug: Placebo- Sugar pill placebo po TID x 14 days

Arm

Intervention/Treatment

Experimental: Domperidone

Domperidone

Drug: Domperidone

10 mg po TID X 14 days

Placebo Comparator: placeob- Sugar pill

Drug: Placebo- Sugar pill

placebo po TID x 14 days

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Mother of an infant born less than 31 weeks gestation
1. Women mechanically expressing breast milk using a double collecting system
1. 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
1. 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.
1. Postpartum period equal to or greater than three weeks.

Exclusion Criteria:

1. 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).
1. Experiencing mastitis
1. Having a chronic or debilitating illness.
1. Previous breast surgery
1. Having a known lactose intolerance