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

Study Overview
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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.

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.

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

Conditions
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Low Breast Milk Supply

Intervention / Treatment
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* Drug: Domperidone
* Drug: Placebo- Sugar pill


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Domperidone<br>Domperidone | Drug: Domperidone<br>* 10 mg po TID X 14 days<br>|
| Placebo Comparator: placeob- Sugar pill<br> | Drug: Placebo- Sugar pill<br>* placebo po TID x 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, Domperidone, breast milk, breast milk composition, preterm infant, nutrition