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

March 14, 2025 updated by: Centro Hospitalar de Lisboa Central

The Effect of Domperidone on the Macronutrient and Energy Content of Breastmilk of Mothers With Preterm Delivery, Using a Human Milk Mid-infrared Spectroscopy Analyzer: a Study Protocol

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Study design: This is a single-center observational study based on a convenience cohort of lactating women who have delivered before 37 weeks gestation.

Study period: A consecutive recruitment of participants will be scheduled over 12 months (from February 2, 2025), according to the availability of the observer (M.C.) in charge of the analysis of breast milk in the unit, performed weekly on a routine basis, in order to be fortified if necessary (Cardoso 2023).

Settings: Neonatal Intensive Care Unit (NICU) and Human Milk Bank at Maternidade Dr. Alfredo da Costa, Unidade Local de Saúde São José, Lisbon.

Product to be analyzed: breast milk Demographic variables: Retrieved demographic and clinical variables will include participant age and gestational age at delivery, reported body weight and height closer to the beginning of pregnancy, type of delivery (vaginal or cesarean), parity, pathological conditions during pregnancy (hypertension, pre-eclampsia, gestational diabetes, and intrauterine growth restriction), date of initiation of domperidone, whether it was prescribed by a health professional or on their own initiative, domperidone dosage, and days of lactation at the time of breast milk analyses.

Method of collection and analysis of breast milk: as described in previous studies (Macedo MHNP 2018, Cardoso 2021), mothers will be asked to save milk collected through 24 hours in the same container, in order to minimize daily variability of breast milk composition. The breast milk macronutrient and energy content will be analyzed using the Miris Human Milk analyzer (Miris AB, Uppsala, Sweden).

Measured breast milk macronutrient and energy content: The breast milk macronutrient and energy content will be analyzed using the Miris® Human Milk analyzer (Miris AB, Uppsala, Sweden) following the milk collection and analysis procedures described (Czosnykowska-Łukacka 2018, Macedo MHNP 2018, Cardoso 2021). Before each use, the analyzer will be calibrated using the standard calibration solution (Quan 2020). The breast milk composition will be expressed in densities: Kcal/dL of energy and g/dL of fat, total and true protein, carbohydrates, and ashes (Macedo MHNP 2018, Cardoso 2021).

According to the Unit's routine, the milk of mothers of preterm infants, particularly very preterm infants, is analyzed weekly to assess the need for fortification (Cardoso 2023).

Within-subject differences in the macronutrient and energy milk content will be determined by comparing the value of each parameter (total and true protein, total fat, total carbohydrates and energy) in the last measurement before starting domperidone (M0) with the respective value 14 days after starting (M14).

Estimate of sample size: The study sample size was calculated to detect an effect size of 0.35 between pairs of breastmilk content in total protein, with a significance level of 0.05, and an 80% power; thus, a required sample of 81 infants (67 participants more 20% for drop out) was estimated.

Statistical Analyses Mean of breastmilk macronutrient content will be compared by paired-t test for normal distributed differences or Wilcoxon test if non-normal distributed differences.

Study Type

Observational

Enrollment (Estimated)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1150-199
        • Unidade Local de Saúde São José

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Lactating women who have delivered prematurely using domperidone as a galactagogue

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Test group
Breast milk macronutrient and energy content assessed by mid-infrared spectroscopy method
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.
Reference group
Breast milk macronutrient and energy content assessed by Kjeldahl and Röse-Gottlib methods
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total protein
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
Within-subject difference of breastmilk content in 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
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
Within-subject difference of breastmilk content in 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
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
Within-subject difference of breastmilk content in 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
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
Within-subject difference of breastmilk content in total energy
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
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
The mean of the percentage differences for total protein obtained in the test group will be compared with the correspondent value obtained in the reference group.
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 true protein
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
7The mean of the percentage differences for true protein obtained in the test group will be compared with the correspondent value obtained in the reference group
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 fat
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
The mean of the percentage differences for fat obtained in the test group will be compared with the correspondent value obtained in the reference group
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 carbohydrate
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
The mean of the percentage differences for carbohydrate obtained in the test group will be compared with the correspondent value obtained in the reference group
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 energy
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
The mean of the percentage differences for total energy obtained in the test group will be compared with the correspondent value obtained in the reference group
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar de Lisboa Central

Investigators

  • Study Chair: Daniel Virella, MD, MSc, Unidade Local de Saúde São José

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHULC.CI.633.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Birth

Clinical Trials on Test group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe