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Domperidone on the Composition of Preterm Breastmilk Using a Human Milk Mid-infrared Spectroscopy Analyzer
Sponsor: Centro Hospitalar de Lisboa Central
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.
Official title: The Effect of Domperidone on the Macronutrient and Energy Content of Breastmilk of Mothers With Preterm Delivery, Using a Human Milk Mid-infrared Spectroscopy Analyzer: a Study Protocol
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
81
Start Date
2025-01-08
Completion Date
2025-08-30
Last Updated
2025-03-18
Healthy Volunteers
No
Interventions
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
Locations (1)
Unidade Local de Saúde São José
Lisbon, Portugal