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

NCT06830226 | Enrolling By Invitation

• 1 other identifier: CHULC.CI.633.2025
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast milk; domperidone; energy; galactagogue; human milk analyzer; macronutrients; mid-infrared spectroscopy; premature birth

Outcome Measures

Primary Outcomes (1)

• True protein content

  Within-subject difference of breastmilk content in true protein (protein with nutritional value)

  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

Secondary Outcomes (9)

• Total protein

  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

• Fat

  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

• Carbohydrate

  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

• Total energy content

  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

• Percentage differences for total protein

  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

Study Arms (2)

Test group

Breast milk macronutrient and energy content assessed by mid-infrared spectroscopy method

Dietary Supplement: Test group

Reference group

Breast milk macronutrient and energy content assessed by Kjeldahl and Röse-Gottlib methods

Dietary Supplement: Reference group

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.

Test group

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

Reference group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lactating women who have delivered prematurely using domperidone as a galactagogue

You may qualify if:

• Lactating women who have delivered prematurely using domperidone as a galactagogue, who will consent to participate, and who are not taking other substances or medications acting as galactagogues

You may not qualify if:

• Lactating women do not agree to participate
• Lactating women use domperidone not as a galactagogue
• Lactating women currently or previously taking other substances or medications acting as galactagogues
• Lactating women taking medications that may alter the effect (such as ranitidine) or interact with domperidone (such as haloperidol)
• Lactating women who have the diagnosis of mastitis
• Lactating women with debilitating chronic illness

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead

Study Sites (1)

Unidade Local de Saúde São José

Lisbon, 1150-199, Portugal

Location

Related Publications (2)

• Czosnykowska-Lukacka M, Krolak-Olejnik B, Orczyk-Pawilowicz M. Breast Milk Macronutrient Components in Prolonged Lactation. Nutrients. 2018 Dec 3;10(12):1893. doi: 10.3390/nu10121893.

  PMID: 30513944 RESULT

• Cardoso M, Virella D, Papoila AL, Alves M, Macedo I, E Silva D, Pereira-da-Silva L. Individualized Fortification Based on Measured Macronutrient Content of Human Milk Improves Growth and Body Composition in Infants Born Less than 33 Weeks: A Mixed-Cohort Study. Nutrients. 2023 Mar 22;15(6):1533. doi: 10.3390/nu15061533.

  PMID: 36986263 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk from mothers who have delivered prematurely

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Daniel Virella, MD, MSc

  Unidade Local de Saúde São José

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: January 8, 2025
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-02

Locations

PT (1)