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

January 27, 2006
October 11, 2007
September 2006
Not Provided
  • success of continuing breastfeeding
  • amount of supplementation used
Same as current
Complete list of historical versions of study NCT00284024 on ClinicalTrials.gov Archive Site
  • concentration of domperidone in milk
  • concentration of domperidone and prolactin in milk
  • maternal satisfaction
  • protocol adherence and barriers
Same as current
Not Provided
Not Provided
 
Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply
Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Insufficient Breastmilk Production
Drug: domperidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
September 2007
Not Provided

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00284024
r05-60
No
Not Provided
Hamilton Health Sciences Corporation
The Physicians' Services Incorporated Foundation
Principal Investigator: Katalin Ivanyi, MD McMaster University
McMaster University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP