|
|
|
|
|
|
Sponsors and Collaborators: |
Hamilton Health Sciences The Physicians' Services Incorporated Foundation |
Information provided by: | Hamilton Health Sciences |
ClinicalTrials.gov Identifier: | NCT00284024 |
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 |
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 |
Estimated Enrollment: | 45 |
Study Start Date: | September 2006 |
Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women
Infants
Exclusion Criteria:
Mother
Infant
Canada, Ontario | |||||
Stonechurch Family Health Centre | |||||
Hamilton, Ontario, Canada, L8W 3L2 |
Hamilton Health Sciences |
The Physicians' Services Incorporated Foundation |
Principal Investigator: | Katalin Ivanyi, MD | Hamilton Health Sciences |
Study ID Numbers: | r05-60 |
First Received: | January 27, 2006 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00284024 |
Health Authority: | Canada: Health Canada |
|
|
|
|