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

Sponsor
Centro Hospitalar de Lisboa Central
Study ID
NCT06830226
Status
Enrolling By Invitation

Conditions

  • Insufficient Breast Milk Syndrome
  • Premature Birth

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Test group — DIETARY_SUPPLEMENT
    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 — DIETARY_SUPPLEMENT
    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 Details

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.

Key Dates

First listed
Feb 17, 2025
Start date
Jan 8, 2025
Status verified
Feb 2025
Primary completion
Jul 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
81 participants (estimated)

Arms

  • Arm: Test group
    Breast milk macronutrient and energy content assessed by mid-infrared spectroscopy method
  • Arm: Reference group
    Breast milk macronutrient and energy content assessed by Kjeldahl and Röse-Gottlib methods

Primary Outcome Measure

True protein content [ Time Frame: 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 ]

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