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Completed

NCT Number: NCT00308334

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Domperidone

Drug

10 mg po TID X 14 days

Placebo- Sugar pill

Drug

placebo po TID x 14 days

Primary outcomes

  1. 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 outcomes

  1. 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,

  2. Breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights)

    Time frame: Daily X 14 days

  3. Serum prolactin level

    Time frame: Day 0, 4 and 14

  4. infant weights

    Time frame: daily X 14 days

  5. breastfeeding rates

    Time frame: two weeks after treatment completion and at discharge

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Canadian Nurses Foundation (CNF)
  • Dalhousie University

Registry information

Official study title

A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Mar 29, 2006
Registry last updated
Jun 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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