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

NCT06830226 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2025-03-18

No results posted yet for this 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.

Conditions

  • Insufficient Breast Milk Syndrome
  • Premature Birth

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

  • Centro Hospitalar de Lisboa Central

    lead OTHER

Principal Investigators

  • Daniel Virella, MD, MSc · Unidade Local de Saúde São José

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2025-07-30
Completion
2025-08-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830226 on ClinicalTrials.gov