MedTrace Logo

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

NCT01512225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-04-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Low Milk Supply

Interventions

DRUG

Domperidone maleate

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

DRUG

Placebo Tablet

placebo tablet 10 mg orally three times daily for 14 days

DRUG

Domperidone maleate

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

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Elizabeth V Asztalos, MD · Sunnybrook Research Institute

  • Marsha Campbell-Yeo, PhD · IWK Health Centre

  • Orlando Da Silva, MD · Children's Hospital, London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-10-31
Completion
2016-03-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01512225 on ClinicalTrials.gov