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

Study acronym: DompMilk
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Start date changed from estimate of Mar 2, 2025 to Jan 8, 2025
    • Secondary endpoints: details revised at 9 of 9 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06830226
Lead Sponsor Centro Hospitalar de Lisboa Central
Conditions
(from sponsor)		 Insufficient Breast Milk Syndrome, Premature Birth
Related terms Premature Birth
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov