Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply
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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 |
- success of continuing breastfeeding
- amount of supplementation used
- 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 |
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 |
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| Canada, Ontario | |
| Stonechurch Family Health Centre | |
| Hamilton, Ontario, Canada, L8W 3L2 | |
| 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 May 23, 2013