Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

NCT01512225 | Completed Phase 2 Results DMC

• 1 other identifier: 232-2011
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breastmilk; domperidone; preterm

Outcome Measures

Primary Outcomes (1)

• Increase in Breast Milk Production

  The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).

  Day 0 to day 14

Secondary Outcomes (7)

• Increase in Breast Milk Volume on Day 28

  day 0 to day 28

• Mean Breast Milk Volumes on Day 14

  Day 0 and day 14

• Mean Breast Milk Volumes on Day 28

  day 0 and 28

• Mean Volume Change From Day 0 to Day 14

  days 0 and 14

• Mean Volume Change on the Volume of Milk From Day 15 to Day 28

  day 15 and day 28

Study Arms (2)

Domperidone for days 1 to 28

EXPERIMENTAL

Domperidone maleate tablets 10 mg orally three times daily from days 1 to 28

Drug: Domperidone maleate

Placebo for days 1 to 14 and domperidone for day 15-28

PLACEBO COMPARATOR

Identical placebo tablets 10 mg orally three times daily from days 1 to 14 followed by Domperidone maleate tablets 10 mg orally three times daily from days 15 to 28

Drug: Placebo Tablet; Drug: Domperidone maleate

Interventions

Domperidone maleate DRUG

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

Domperidone for days 1 to 28

Placebo Tablet DRUG

placebo tablet 10 mg orally three times daily for 14 days

Placebo for days 1 to 14 and domperidone for day 15-28

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• mothers of a preterm infant born \< 30 completed weeks gestation (23 0/7-29 6/7 weeks)
• postpartum period of 7-21 days
• mechanically pumping a minimum average of 6 times a day in the 4-7 days prior to enrollment
• experiencing inadequate milk supply defined as providing \< 100% of the average of the daily nutritional intake during the previous 72-hour period prior to enrollment based on a fluid intake of 250 mL/kg/d or experiencing a clinical reduction of approximately 20% from a peak volume during the previous 72-hour period prior to enrollment

You may not qualify if:

• history of known or suspected cardiac dysrhythmias (tachyarrhythmia, Q-Tc prolongation) or currently on an anti-arrhythmic medication
• currently experiencing mastitis
• previous breast surgery, including augmentation or reduction, nipple piercing and/or the use of nipple rings/studs within the last year, or any reduction
• known to have a prolactin-releasing pituitary tumor
• receiving medications known to alter the metabolism and pharmacokinetics of domperidone (eg. oral "azole" antifungals, erythromycin antibiotics, monoamine oxidase inhibitors (MAO) inhibitors) or medications that have dopaminergic or antidopaminergic activity or affect prolactin levels
• mothers of higher order pregnancies (triplet, or more)
• currently smoking 6 or more cigarette per day as reported by the mother

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (5)

• Asztalos EV, Campbell-Yeo M, da Silva OP, Ito S, Kiss A, Knoppert D; EMPOWER Study Collaborative Group. Enhancing Human Milk Production With Domperidone in Mothers of Preterm Infants. J Hum Lact. 2017 Feb;33(1):181-187. doi: 10.1177/0890334416680176. Epub 2017 Jan 20.

  PMID: 28107101 RESULT

• Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Role of days postdelivery on breast milk production: a secondary analysis from the EMPOWER trial. Int Breastfeed J. 2019 Jun 4;14:21. doi: 10.1186/s13006-019-0215-z. eCollection 2019.

  PMID: 31171928 DERIVED

• Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; <italic>EMPOWER</italic> Study Collaborative Group. Evaluating the Effect of a 14-Day Course of Domperidone on Breast Milk Production: A Per-Protocol Analysis from the EMPOWER Trial. Breastfeed Med. 2019 Mar;14(2):102-107. doi: 10.1089/bfm.2018.0175. Epub 2018 Dec 13.

  PMID: 30543461 DERIVED

• Asztalos EV, Kiss A, da Silva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Pregnancy gestation at delivery and breast milk production: a secondary analysis from the EMPOWER trial. Matern Health Neonatol Perinatol. 2018 Nov 5;4:21. doi: 10.1186/s40748-018-0089-x. eCollection 2018.

  PMID: 30410781 DERIVED

• Asztalos EV, Campbell-Yeo M, daSilva OP, Kiss A, Knoppert DC, Ito S. Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial). BMC Pregnancy Childbirth. 2012 Aug 31;12:87. doi: 10.1186/1471-2393-12-87.

  PMID: 22935052 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Elizabeth Asztalos
• Organization: Sunnybrook Research Institute

elizabeth.asztalos@sunnybrook.ca

416-480-6100,

Study Officials

• Elizabeth V Asztalos, MD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

• Marsha Campbell-Yeo, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

• Orlando Da Silva, MD

  Children's Hospital, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 19, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)