Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk
2006

Effect of Domperidone on Breast Milk Composition

Sample size: 44 publication Evidence: moderate

Author Information

Author(s): Marsha L Campbell-Yeo, Alexander C Allen, Joseph K S Joseph, Joyce M Ledwidge, Victoria M Allen, Kent C Dooley

Primary Institution: IWK Health Centre and Dalhousie University

Hypothesis

The macronutrient composition (protein, fat and calories) of human breast milk will be significantly altered by the administration of domperidone.

Conclusion

Domperidone may significantly change the nutrient content of breast milk, which could impact feeding practices for preterm infants.

Supporting Evidence

  • Domperidone has been shown to safely increase the milk supply of lactating women.
  • Current guidelines for fortification of human milk for premature infants do not distinguish between those using or not using domperidone.
  • Significant changes in nutrient content of breast milk could necessitate alterations in feeding practices for preterm infants.

Takeaway

This study looks at how a medicine called domperidone affects the nutrients in breast milk for mothers of premature babies. If it helps make the milk better, it could change how we feed these babies.

Methodology

Mothers of infants delivered at less than 31 weeks gestation will be randomized to receive domperidone or placebo for 14 days, with breast milk samples collected for analysis.

Potential Biases

Potential biases may arise from the double-blind design, but randomization aims to mitigate these risks.

Limitations

The study may not account for all variables affecting breast milk composition, and the sample size is relatively small.

Participant Demographics

Mothers of very preterm infants (less than 31 weeks gestation) who are at least 3 weeks postpartum.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-2393-6-17

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