Effect of domperidone on the composition of preterm human breast milk

Pediatrics. 2010 Jan;125(1):e107-14. doi: 10.1542/peds.2008-3441. Epub 2009 Dec 14.


Objective: Domperidone is increasingly prescribed to improve breast milk volume despite a lack of evidence regarding its effects on breast milk composition. We examined the effect of domperidone on the nutrient composition of breast milk.

Patients and methods: Forty-six mothers who had delivered infants at <31 weeks' gestation, who experienced lactation failure, were randomly assigned to receive domperidone or placebo for 14 days. Protein, energy, fat, carbohydrate, sodium, calcium, and phosphate levels in breast milk were measured on days 0, 4, 7, and 14, serum prolactin levels were measured on days 0, 4, and 14, and total milk volume was recorded daily. Mean within-subject changes in nutrients and milk volumes were examined.

Results: Maternal and infant characteristics, serum prolactin level, and breast milk volume and composition were not significantly different between domperidone and placebo groups on day 0. By day 14, breast milk volumes increased by 267% in the domperidone-treated group and by 18.5% in the placebo group (P = .005). Serum prolactin increased by 97% in the domperidone group and by 17% in the placebo group (P = .07). Mean breast milk protein declined by 9.6% in the domperidone group and increased by 3.6% in the placebo group (P = .16). Changes in energy, fat, carbohydrate, sodium, and phosphate content were also not significantly different between groups. Significant increases were observed in breast milk carbohydrate (2.7% vs -2.7%; P = .05) and calcium (61.8% vs -4.4%; P = .001) in the domperidone versus placebo groups. No significant adverse events were observed among mothers or infants.

Conclusion: Domperidone increases the volume of breast milk of preterm mothers experiencing lactation failure, without substantially altering the nutrient composition.

Trial registration: ClinicalTrials.gov NCT00308334.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Domperidone / administration & dosage*
  • Dopamine Antagonists / administration & dosage*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Infant, Newborn
  • Infant, Premature*
  • Intensive Care Units, Neonatal
  • Lactation / drug effects*
  • Male
  • Milk, Human / chemistry*
  • Nova Scotia
  • Pregnancy
  • Probability
  • Reference Values
  • Treatment Outcome


  • Dopamine Antagonists
  • Domperidone

Associated data

  • ClinicalTrials.gov/NCT00308334