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

This study has been terminated.
( Unable to recruit participants )

Sponsors and Collaborators: Hamilton Health Sciences
The Physicians' Services Incorporated Foundation
Information provided by: Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00284024
  Purpose

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 Intervention Phase
Insufficient Breastmilk Production
Drug: domperidone
Phase II

MedlinePlus related topics:   Breast Feeding   

ChemIDplus related topics:   Domperidone    Domperidone maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study

Further study details as provided by Hamilton Health Sciences:

Primary Outcome Measures:
  • success of continuing breastfeeding
  • amount of supplementation used

Secondary Outcome Measures:
  • concentration of domperidone in milk
  • concentration of domperidone and prolactin in milk
  • maternal satisfaction
  • protocol adherence and barriers

Estimated Enrollment:   45
Study Start Date:   September 2006
Study Completion Date:   September 2007

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.

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284024

Locations
Canada, Ontario
Stonechurch Family Health Centre    
      Hamilton, Ontario, Canada, L8W 3L2

Sponsors and Collaborators
Hamilton Health Sciences
The Physicians' Services Incorporated Foundation

Investigators
Principal Investigator:     Katalin Ivanyi, MD     Hamilton Health Sciences    
  More Information


Study ID Numbers:   r05-60
First Received:   January 27, 2006
Last Updated:   October 11, 2007
ClinicalTrials.gov Identifier:   NCT00284024
Health Authority:   Canada: Health Canada

Keywords provided by Hamilton Health Sciences:
breastfeeding  
domperidone  
efficacy  
randomized controlled trial  
compliance  

Study placed in the following topic categories:
Dopamine
Domperidone

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Agents
Dopamine Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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