Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply

Study Overview
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Brief Summary
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This study is testing if a medication called domperidone will help women produce more milk so that they can keep breastfeeding and not use formula. The study is also testing what dose of domperidone works best to increase breast milk production.

Detailed Description
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Breastfeeding alone, until an infant is 6 months of age, is the best form of infant nutrition. There are many ways to help women breastfeed when they are having difficulties with the process, mostly involving support from a lactation consultant. However, some women, despite all appropriate non-medical interventions and support do not produce sufficient breast milk to meet the nutritional needs of their infant. This is a feasibility study to determine how domperidone affects breast milk production in women with insufficient milk supply feeding term infants. This project will serve to refine and advance the design of a subsequent full-scale clinical trial. The goal of this study is to: a) refine the intervention strategy (drug dosage), b) to define the target population and ensure adequate enrollment, c) assess protocol adherence and subject retention, and d) collect preliminary data to establish measures of clinical efficacy.

Official Title
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Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study

Conditions
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Insufficient Breastmilk Production

Intervention / Treatment
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* Drug: domperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women healthy women inadequate milk supply read/speak English Infants healthy term infants (≥ 38 weeks gestational age) age ≥ 2wks and ≤3mths surpassed birth weight Exclusion Criteria: Mother cardiac anomalies breast or endocrine abnormalities (i.e. breast CA, pituitary adenomas) medications contraindicated with domperidone use drug or alcohol use use of hormonal contraception Infant physical anomalies making breastfeeding difficult (i.e. cleft palate) cardiac anomalies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: domperidone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of continuing breastfeeding |  |  | 
| amount of supplementation used |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of domperidone in milk |  |  | 
| concentration of domperidone and prolactin in milk |  |  | 
| maternal satisfaction |  |  | 
| protocol adherence and barriers |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breastfeeding, domperidone, efficacy, randomized controlled trial, compliance