Insufficient Breastmilk Production
Conditions
Keywords
breastfeeding, domperidone, efficacy, randomized controlled trial, compliance
Brief summary
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.
Detailed description
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.
Interventions
DRUGdomperidone
Sponsors
The Physicians' Services Incorporated Foundation
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| success of continuing breastfeeding | — |
| amount of supplementation used | — |
Secondary
| Measure | Time frame |
|---|---|
| maternal satisfaction | — |
| protocol adherence and barriers | — |
| concentration of domperidone in milk | — |
| concentration of domperidone and prolactin in milk | — |
Countries
Canada
Outcome results
None listed