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

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.
 
ClinicalTrials.gov Identifier: NCT00308334
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : June 11, 2009
Sponsor:
Collaborators:
Canadian Nurses Foundation (CNF)
Dalhousie University
Information provided by:
IWK Health Centre

Tracking Information
First Submitted Date  ICMJE March 27, 2006
First Posted Date  ICMJE March 29, 2006
Last Update Posted Date June 11, 2009
Study Start Date  ICMJE October 2003
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2006)
The protein levels from breast milk, collected on days 0, 4, 7, and 14 will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2006)
  • The fat, carbohydrate, lactose, energy, calcium, phosphorus and sodium content of breast milk, collected on days 0, 4, 7, and 14, will be compared between domperidone and placebo groups.
  • Other outcomes
  • Daily breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights)
  • serum prolactin level
  • daily infant weights
  • breastfeeding rates two weeks after treatment completion and at discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk
Official Title  ICMJE A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Breast Milk Supply
Intervention  ICMJE
  • Drug: Domperidone
    10 mg po TID X 14 days
  • Drug: Placebo- Sugar pill
    placebo po TID x 14 days
Study Arms  ICMJE
  • Experimental: Domperidone
    Domperidone
    Intervention: Drug: Domperidone
  • Placebo Comparator: placeob- Sugar pill
    Intervention: Drug: Placebo- Sugar pill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2009)
46
Original Enrollment  ICMJE
 (submitted: March 27, 2006)
44
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00308334
Other Study ID Numbers  ICMJE 2498
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marsha Campbell-Yeo, IWK Health Centre
Study Sponsor  ICMJE IWK Health Centre
Collaborators  ICMJE
  • Canadian Nurses Foundation (CNF)
  • Dalhousie University
Investigators  ICMJE
Principal Investigator: Marsha L Campbell-Yeo, MN NNP-BC PhDc IWK Health Centre
PRS Account IWK Health Centre
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP