Domperidone on the Composition of Preterm Breastmilk Using a Human Milk Mid-infrared Spectroscopy Analyzer

Condition(s) studied

Investigational drug(s) / intervention(s)

Test group: In this group the Miris Human Milk analyzer will be used, consisting of a real-time mid-infrared technology that directly measures the concentration of protein, fat and carbohydrate, and calculates the energy content based on direct measurements.

Reference group: In this group the Kjeldahl method will be used to assess total nitrogen concentration, the Röse-Gottlib method to assess fat concentration, and energy and carbohydrate concentration will be calculated by differences. Kjeldahl and the Röse-Gottlib are considered reference methods

Study summary

Maintaining milk production in lactating mothers who have delivered prematurely can be a challenge. In these cases, domperidone has been the most commonly used pharmacologic galactagogue. There are several studies on the effect of this drug on the volume of milk produced, but data on its effect on the macronutrient and energy content is scarce. The mid-infrared spectroscopy is a convenient validated method to assess human milk macronutrient and energy content because it requires little training for its operation and a small volume of milk. This study aims to determine the effect of domperidone on the macronutrient and energy content of milk from women who have delivered prematurely, and to compare the results obtained with those reported using reference methods for this analysis.

Eligibility

Primary outcome measure(s)

• True protein content — Between the last assessment before starting domperidone and the assessment 14 days after starting domperidone. The difference value between 14 days after domperidone and before starting it, expressed as percentage of the value before starting domperidone
  Within-subject difference of breastmilk content in true protein (protein with nutritional value)

Trial sites (1)

More Centro Hospitalar de Lisboa Central trials in Portugal