Insufficient Breast Milk SyndromeDompMilkNCT06830226
Domperidone on the Composition of Preterm Breastmilk Using a Human Milk Mid-infrared Spectroscopy Analyzer
An observational study of Insufficient Breast Milk Syndrome and Premature Birth, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Insufficient Breast Milk Syndrome, Premature Birth
- What is being tested?
- Test group and Reference group
- How many people
- 81 participants
- Where
- 1 sitePortugal
- Study dates
- 8 Jan 2025to 30 Aug 2025
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lactating women who have delivered prematurely using domperidone as a galactagogue
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Insufficient Breast Milk Syndrome, Premature Birth
- Being tested
- Test group, Reference group
- Keywords
- breast milk, domperidone, energy, galactagogue, human milk analyzer, macronutrients, mid-infrared spectroscopy, premature birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test groupDietary 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 groupDietary 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 group | Role | What they receive |
|---|---|---|
| Test group | Breast milk macronutrient and energy content assessed by mid-infrared spectroscopy method Receives: Dietary Supplement: Test group | |
| Reference group | Breast milk macronutrient and energy content assessed by Kjeldahl and Röse-Gottlib methods Receives: Dietary Supplement: Reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
True protein content
Within-subject difference of breastmilk content in true protein (protein with nutritional value)
Measured: 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
Within-subject difference of breastmilk content in total protein
Measured: 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
Within-subject difference of breastmilk content in fat
Measured: 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
Within-subject difference of breastmilk content in carbohydrate
Measured: 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
Within-subject difference of breastmilk content in total energy
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start8 Jan 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insufficient Breast Milk SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 81 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Lisboa Central
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Virella, MD, MSc, Study chair, Unidade Local de Saude Sao Jose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830226
- Sponsor's protocol ID
- CHULC.CI.633.2025
- Acronym
- DompMilk
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30513944Cardoso 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.
PubMed 36986263
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06830226
- Acronym / sponsor ID
- DompMilk / CHULC.CI.633.2025
- Conditions
- Insufficient Breast Milk Syndrome, Premature Birth
- Keywords
- breast milk, domperidone, energy, galactagogue, human milk analyzer, macronutrients, mid-infrared spectroscopy, premature birth
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Lisboa CentralUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Dietary Supplement: Test groupBreast milk macronutrient and energy content assessed by mid-infrared spectroscopy method |
| Reference group | – | Dietary Supplement: Reference groupBreast milk macronutrient and energy content assessed by Kjeldahl and Röse-Gottlib methods |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lactating women who have delivered prematurely using domperidone as a galactagogue
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test groupIn 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 | Test group |
| Reference groupIn 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 | Dietary supplement | Reference group |
Primary outcome
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)
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Results publication: PubMed 30513944Czosnykowska-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.
- Results publication: PubMed 36986263Cardoso 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Virella, MD, MSc study chair
Unidade Local de Saude Sao Jose
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insufficient Breast Milk Syndrome and Premature Birth, run by Centro Hospitalar de Lisboa Central at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06830226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.