NCT00284024

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insufficient Breastmilk Production

Interventions

Type	Name	Description
DRUG	domperidone

Timeline

• Start date: 2006-09-01
• Completion: 2007-09-01
• First posted: 2006-01-31
• Last updated: 2007-10-15

Locations

1 site across 1 country: Canada