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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308334
First Posted: March 29, 2006
Last Update Posted: June 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Nurses Foundation (CNF)
Dalhousie University
Information provided by:
IWK Health Centre
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

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, ]
  • Breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights) [ Time Frame: Daily X 14 days ]
  • Serum prolactin level [ Time Frame: Day 0, 4 and 14 ]
  • infant weights [ Time Frame: daily X 14 days ]
  • breastfeeding rates [ Time Frame: two weeks after treatment completion and at discharge ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: March 27, 2006
First Posted: March 29, 2006
Last Update Posted: June 11, 2009
Last Verified: June 2009

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
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action