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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284024
Recruitment Status : Terminated (Unable to recruit participants)
First Posted : January 31, 2006
Last Update Posted : October 15, 2007
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Domperidone

Arms and Interventions
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Outcome Measures
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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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284024


Locations
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Canada, Ontario
Stonechurch Family Health Centre
Hamilton, Ontario, Canada, L8W 3L2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Katalin Ivanyi, MD McMaster University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00284024    
Other Study ID Numbers: r05-60
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: October 15, 2007
Last Verified: October 2007
Keywords provided by McMaster University:
breastfeeding
domperidone
efficacy
randomized controlled trial
compliance
Additional relevant MeSH terms:
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Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action