CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Domperidone maleate +2 moredrug
Likely dose
Domperidone maleate 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01512225
NCT01512225Phase 2Completed
CompareCT.gov

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Sunnybrook Health Sciences Centre·interventional·Posted Jan 19, 2012·Updated Apr 20, 2017

In Brief

A Phase 2 clinical trial evaluating Domperidone maleate and Placebo Tablet for Low Milk Supply. Completed, enrolled 90 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of Domperidone in those mothers who are identified as having difficulty with breast milk production to meet the nutritional needs of their infant in the neonatal intensive are unit hospitalization setting, and to determine how it should be considered in the care of mothers and their preterm infants without causing undesirable effects to either the mother or infant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Milk Supply
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 19, 2012
Enrollment StartMay 1, 2012
Primary CompletionOct 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.5 years ago

Interventions

Domperidone maleatedrug

domperidone maleate tablet 10 mg orally three times daily for 28 days

Placebo Tabletdrug

placebo tablet 10 mg orally three times daily for 14 days

Domperidone maleatedrug

domperidone maleate tablet 10 mg orally three times daily for 14 days