Clinical Trial

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

Study acronym: DompMilk
Enrolling by Invitation
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Record status
This record was last updated March 18, 2025 (before its estimated July 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-11.
Trial Details
NCT Number NCT06830226
Lead Sponsor Centro Hospitalar de Lisboa Central
Conditions Insufficient Breast Milk Syndrome, Premature Birth
Enrollment 81 participants
Start Date 2025-01-08
Primary Completion 2025-07-30 (estimated)
Study Completion 2025-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-18