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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: domperidone

Primary Measures

• success of continuing breastfeeding
• amount of supplementation used

Secondary Measures

• concentration of domperidone in milk
• concentration of domperidone and prolactin in milk
• maternal satisfaction
• protocol adherence and barriers

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Hamilton Health Sciences

Overall Clinical Trial Officials and Contacts

Katalin Ivanyi, MD Principal Investigator McMaster University  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00284024

Study ID Number: r05-60

ClinicalTrials.gov Identifier: NCT00284024

Health Authority: Canada: Health Canada