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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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

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Low Breast Milk Supply

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Domperidone

Group Type EXPERIMENTAL

Domperidone

Intervention Type DRUG

10 mg po TID X 14 days

placeob- Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo- Sugar pill

Intervention Type DRUG

placebo po TID x 14 days

Interventions

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Domperidone

10 mg po TID X 14 days

Intervention Type DRUG

Placebo- Sugar pill

placebo po TID x 14 days

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No