Clinical trial NCT00284024: Effectiveness of Domperidone to Increase Breastmilk Supply in Mothers With Low Supply
Official title: Assessing the Feasibility of Testing Domperidone's Effect on Breastfeeding in Women With Insufficient Breast Milk: An RCT Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Insufficient Breastmilk Production
Keywords: breastfeeding
domperidone
efficacy
randomized controlled trial
compliance
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2006-01-31
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: success of continuing breastfeeding
measure: amount of supplementation used
Secondary outcomes:
measure: concentration of domperidone in milk
measure: concentration of domperidone and prolactin in milk
measure: maternal satisfaction
measure: protocol adherence and barriers
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Stonechurch Family Health Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Katalin Ivanyi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.