Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply

Hamilton Health Sciences (HHS)

Status and phase: Terminated; Phase 2

Conditions: Insufficient Breastmilk Production

Treatments: Drug: domperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00284024

r05-60

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind