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

• Sponsor: Hamilton Health Sciences Corporation (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00284024
• Collaborator: The Physicians' Services Incorporated Foundation (Other)
• Enrollment: 45
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insufficient Breastmilk Production	Drug: domperidone	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study
• Study Start Date: Sep 1, 2006
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. success of continuing breastfeeding []

2. amount of supplementation used []

Secondary Outcome Measures

1. concentration of domperidone in milk []

2. concentration of domperidone and prolactin in milk []

3. maternal satisfaction []

4. protocol adherence and barriers []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stonechurch Family Health Centre	Hamilton	Ontario	Canada	L8W 3L2

Sponsors and Collaborators

• Hamilton Health Sciences Corporation
• The Physicians' Services Incorporated Foundation

Investigators

• Principal Investigator: Katalin Ivanyi, MD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00284024
• Other Study ID Numbers: r05-60
• First Posted: Jan 31, 2006
• Last Update Posted: Oct 15, 2007
• Last Verified: Oct 1, 2007

• Keywords provided by , ,: breastfeeding; domperidone; efficacy; randomized controlled trial; compliance
• Additional relevant MeSH terms: Domperidone

Study Results

No Results Posted as of Oct 15, 2007