Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284024
|Stonechurch Family Health Centre|
|Hamilton, Ontario, Canada, L8W 3L2|
|Principal Investigator:||Katalin Ivanyi, MD||McMaster University|