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

Insufficient Breastmilk Production Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00284024
• Other study ID #: r05-60
• Status: Terminated
• Phase: Phase 2
• First received: January 27, 2006
• Last updated: October 11, 2007
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insufficient Breastmilk Production

Intervention

Drug:
• domperidone

Locations

Country	Name	City	State
Canada	Stonechurch Family Health Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success of continuing breastfeeding
Primary	amount of supplementation used
Secondary	concentration of domperidone in milk
Secondary	concentration of domperidone and prolactin in milk
Secondary	maternal satisfaction
Secondary	protocol adherence and barriers