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

Phase 2

Terminated

• Conditions: Insufficient Breastmilk Production

• Registration Number: NCT00284024
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-31
• Study Start: 2006-09
• Study Completion: 2007-09
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-11
• Last Update Posted: 2007-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
success of continuing breastfeeding
amount of supplementation used

Secondary Outcome Measures

Name	Time	Method
concentration of domperidone in milk
concentration of domperidone and prolactin in milk
maternal satisfaction
protocol adherence and barriers

Trial Locations

Locations (1)

Stonechurch Family Health Centre; 🇨🇦 Hamilton, Ontario, Canada