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

This study has been terminated.
(Unable to recruit participants)
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00284024
First received: January 27, 2006
Last updated: October 11, 2007
Last verified: October 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by McMaster University:

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 Corporation
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Katalin Ivanyi, MD McMaster University
  More Information

No publications provided

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

Keywords provided by McMaster University:
breastfeeding
domperidone
efficacy
randomized controlled trial
compliance

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

ClinicalTrials.gov processed this record on April 17, 2014