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Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk

This study has been completed.
Sponsor:
Collaborators:
Canadian Nurses Foundation (CNF)
Dalhousie University
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00308334
First received: March 27, 2006
Last updated: June 10, 2009
Last verified: June 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.


Condition Intervention Phase
Low Breast Milk Supply
 Drug: Domperidone
Drug: Placebo- Sugar pill
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk

Resource links provided by NLM:

Drug Information available for: Domperidone
U.S. FDA Resources

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • The protein levels from breast milk will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days). [ Time Frame: days 0, 4, 7, and 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The fat, carbohydrate, lactose, energy, calcium, phosphorus and sodium content of breast milk will be compared between domperidone and placebo groups. [ Time Frame: days 0, 4, 7, and 14, ] [ Designated as safety issue: No ]
  • Breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights) [ Time Frame: Daily X 14 days ] [ Designated as safety issue: No ]
  • Serum prolactin level [ Time Frame: Day 0, 4 and 14 ] [ Designated as safety issue: No ]
  • infant weights [ Time Frame: daily X 14 days ] [ Designated as safety issue: No ]
  • breastfeeding rates [ Time Frame: two weeks after treatment completion and at discharge ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: October 2003
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Domperidone
Domperidone
 Drug: Domperidone
10 mg po TID X 14 days
Placebo Comparator: placeob- Sugar pill Drug: Placebo- Sugar pill
placebo po TID x 14 days

Detailed Description:

Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • i. Mother of an infant born less than 31 weeks gestation
  • ii. Women mechanically expressing breast milk using a double collecting system
  • iii. Experiencing lactation failure indicated by at least one of the following: A decreasing milk supply (by greater than 30 percent from peak volume based on maternal account) An inability to provide adequate breast milk to meet the daily nutritional intake of their infant
  • iv. Women who have had little or no improvement in milk production following education/counseling with a lactation consultant/Neonatal Intensive Care nurse with respect to non-pharmacological techniques.
  • v. Postpartum period equal to or greater than three weeks.

Exclusion Criteria:

  • i. Participants receiving any medication known to alter the effect of domperidone (e.g.cimetidine, ranitidine, famotidine, and nizatidine) or medication that interacts with domperidone (e.g. haloperidol, lithium).
  • ii. Experiencing mastitis
  • iii. Having a chronic or debilitating illness.
  • iv. Previous breast surgery
  • v. Having a known lactose intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308334

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Nurses Foundation (CNF)
Dalhousie University
Investigators
Principal Investigator: Marsha L Campbell-Yeo, MN NNP-BC PhDc IWK Health Centre
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marsha Campbell-Yeo, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00308334     History of Changes
Other Study ID Numbers: 2498
Study First Received: March 27, 2006
Last Updated: June 10, 2009
Health Authority: Canada: Health Canada

Keywords provided by IWK Health Centre:
Domperidone
breast milk
breast milk composition
 preterm infant
neonate
nutrition

Additional relevant MeSH terms:
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013