IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
NCT Number: NCT00308334
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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Interventional
Phase 2 / Phase 3
Halifax, Nova Scotia, B3K 6R8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 mg po TID X 14 days
placebo po TID x 14 days
Time frame: days 0, 4, 7, and 14
Time frame: days 0, 4, 7, and 14,
Time frame: Daily X 14 days
Time frame: Day 0, 4 and 14
Time frame: daily X 14 days
Time frame: two weeks after treatment completion and at discharge
IWK Health Centre
Other
A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk
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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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