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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
10 mg po TID X 14 days
placebo po TID x 14 days
IWK Health Centre
Halifax, Nova Scotia, Canada
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
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
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