Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply
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|ClinicalTrials.gov Identifier: NCT00284024|
Recruitment Status : Terminated (Unable to recruit participants)
First Posted : January 31, 2006
Last Update Posted : October 15, 2007
|Condition or disease||Intervention/treatment||Phase|
|Insufficient Breastmilk Production||Drug: domperidone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study|
|Study Start Date :||September 2006|
|Actual Study Completion Date :||September 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284024
|Stonechurch Family Health Centre|
|Hamilton, Ontario, Canada, L8W 3L2|
|Principal Investigator:||Katalin Ivanyi, MD||McMaster University|