Human Milk NutritionNCT06904924
Determinants of the Nutritional Composition of Donor Human Milk
An observational study of Human Milk Nutrition, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment. In special circumstances, such as prematurity or illness, breast milk is not always available, and donor human milk (DHM) is an option. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Human Milk Nutrition
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- May 2025to Jun 2028
- 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: Human milk donors from BLHN
Who may be able to join
- Human milk donors at BLHN
- Informed consent of the participant
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Centro Hospitalar Universitário São João (CHUSJ)
Porto, 4200-319
About this study
Official title: Study of Determinants of the Nutritional Composition of Donor Human Milk
Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment. In special circumstances, such as prematurity or illness, breast milk is not always available, and donor human milk (DHM) is an option. Some studies have reported growth retardation in babies fed DHM, probably due to the less adequate nutritional composition. There are several factors that contribute to changes in its nutritional composition. Among the various factors, the following are worth highlighting: wide variety of donors with different characteristics (e.g. gestational age, lactation phase, diet); inconsistency of the collection method; impact of milk processing, i.e. the pasteurization process.
As the Human Milk Bank of North (BLHN - Banco de Leite Humano do Norte) is the first in the North region of Portugal, and there are few studies developed in this area in Portugal, the present project aims to study the influence of the following factors on the composition of the DHM:
- Pasteurization process;
- Dietary habits of donors;
- Body composition of donors.
Read the detailed description
Study design and sampling: observational study with a cross-sectional and prospective design. The sample will consist of mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.
Data collection: in order to meet the objectives of the research project, a questionnaire was drawn up for the participants, to be administered on paper, in an interview format, in the context of an outpatient consultation.
The questionnaire lasts around 20 minutes and consists of sociodemographic information (age, household composition, marital status, nationality, educational qualifications, profession); personal history (pathologies, number of pregnancies and births, date of last birth, gender, age, birth weight and length of the newborn, presence of gestational diabetes, hypertension in pregnancy, pre-eclampsia, term or pre-term birth, twin pregnancy); anthropometric data and body composition of the donor; food frequency questionnaire; physical activity; nutritional composition of the donated milk before and after processing (pasteurization).
- Conditions
- Human Milk Nutrition
- Keywords
- Donor human milk, Human milk nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Human milk donor | Mothers who donate human milk to the BLHN of the Centro Hospitalar de São João. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy of donated human milk
Determination of the energy composition of the donated human milk (kcal/100mL).
Measured: At baseline before pasteurization; at baseline after pasteurization.
Total protein levels of donated human milk
Determination of the total protein levels of the donated human milk (g/100mL).
Measured: At baseline before pasteurization; at baseline after pasteurization.
True protein levels of donated human milk
Determination of true protein levels of the donated human milk (g/100mL).
Measured: At baseline before pasteurization; at baseline after pasteurization.
Fat levels of donated human milk
Determination of fat levels of the donated human milk (g/100mL).
Measured: At baseline before pasteurization; at baseline after pasteurization.
Carbohydrates levels of donated human milk
Determination of carbohydrates levels of donated human milk (g/100mL).
Measured: At baseline before pasteurization; at baseline after pasteurization.
Body mass index of the donor
Height (m) and weight (kg) at the beginning and at the end of pregnancy of the donor to calculate pre-pregnancy body mass index (BMI) (kg/m^2) and the post-pregnancy BMI (kg/m^2).
Measured: At baseline
Gestational weight gain of the donor
Gestational weight gain (kg) by the donor.
Measured: At baseline
Waist circunference of the donor.
Waist circunference (cm) of the donor.
Measured: At baseline
Hip circunference of the donor
Hip circunference (cm) of the donor.
Measured: At baseline
Assessment of the donors' eating habits
The dietary habits of the previous year will be assessed using a semiquantitative food frequency questionnaire (FFQ) validated for the Portuguese adult population.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Milk NutritionStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Banco de Leite Humano do Norte, Centro Hospitalar De São João, E.P.E.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904924
- Sponsor's protocol ID
- BLHN/ Pediatric Nutrition
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Determinants of the Nutritional Composition of Donor Human Milk
- ClinicalTrials.gov ID
- NCT06904924
- Acronym / sponsor ID
- BLHN/ Pediatric Nutrition
- Conditions
- Human Milk Nutrition
- Keywords
- Donor human milk, Human milk nutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Banco de Leite Humano do Norte, Centro Hospitalar De São João, E.P.E.
- Study start
- May 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Apr 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.
Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment. In special circumstances, such as prematurity or illness, breast milk is not always available, and donor human milk (DHM) is an option. Some studies have reported growth retardation in babies fed DHM, probably due to the less adequate nutritional composition. There are several factors that contribute to changes in its nutritional composition. Among the various factors, the following are worth highlighting: wide variety of donors with different characteristics (e.g. gestational age, lactation phase, diet); inconsistency of the collection method; impact of milk processing, i.e. the pasteurization process.
As the Human Milk Bank of North (BLHN - Banco de Leite Humano do Norte) is the first in the North region of Portugal, and there are few studies developed in this area in Portugal, the present project aims to study the influence of the following factors on the composition of the DHM:
- Pasteurization process;
- Dietary habits of donors;
- Body composition of donors.
Detailed description
Study design and sampling: observational study with a cross-sectional and prospective design. The sample will consist of mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.
Data collection: in order to meet the objectives of the research project, a questionnaire was drawn up for the participants, to be administered on paper, in an interview format, in the context of an outpatient consultation.
The questionnaire lasts around 20 minutes and consists of sociodemographic information (age, household composition, marital status, nationality, educational qualifications, profession); personal history (pathologies, number of pregnancies and births, date of last birth, gender, age, birth weight and length of the newborn, presence of gestational diabetes, hypertension in pregnancy, pre-eclampsia, term or pre-term birth, twin pregnancy); anthropometric data and body composition of the donor; food frequency questionnaire; physical activity; nutritional composition of the donated milk before and after processing (pasteurization).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human milk donor | – | –Mothers who donate human milk to the BLHN of the Centro Hospitalar de São João. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Human milk donors from BLHN
Key inclusion criteria (2 listed)
- Human milk donors at BLHN
- Informed consent of the participant
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy of donated human milk
Time frame: At baseline before pasteurization; at baseline after pasteurization.
Determination of the energy composition of the donated human milk (kcal/100mL).
Total protein levels of donated human milk
Time frame: At baseline before pasteurization; at baseline after pasteurization.
Determination of the total protein levels of the donated human milk (g/100mL).
True protein levels of donated human milk
Time frame: At baseline before pasteurization; at baseline after pasteurization.
Determination of true protein levels of the donated human milk (g/100mL).
Fat levels of donated human milk
Time frame: At baseline before pasteurization; at baseline after pasteurization.
Determination of fat levels of the donated human milk (g/100mL).
Carbohydrates levels of donated human milk
Time frame: At baseline before pasteurization; at baseline after pasteurization.
Determination of carbohydrates levels of donated human milk (g/100mL).
Body mass index of the donor
Time frame: At baseline
Height (m) and weight (kg) at the beginning and at the end of pregnancy of the donor to calculate pre-pregnancy body mass index (BMI) (kg/m^2) and the post-pregnancy BMI (kg/m^2).
Gestational weight gain of the donor
Time frame: At baseline
Gestational weight gain (kg) by the donor.
Waist circunference of the donor.
Time frame: At baseline
Waist circunference (cm) of the donor.
Hip circunference of the donor
Time frame: At baseline
Hip circunference (cm) of the donor.
Assessment of the donors' eating habits
Time frame: At baseline
The dietary habits of the previous year will be assessed using a semiquantitative food frequency questionnaire (FFQ) validated for the Portuguese adult population.
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 1 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Human Milk Nutrition
Recruiting
Protocol-driven Nutrition in Preterm Infants
Preterm Infants
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Recruiting
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Breastfeeding, Dietary Intervention
RecruitingPhase 1/2
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
Extreme Prematurity, Enteral Nutrition
RecruitingPhase 4
Pasteurised Donor Human Milk Supplementation for Term Babies
Neonatal Hypoglycemia, Metabolic Complication
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.
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 Human Milk Nutrition, run by Universidade do Porto 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Apr 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?
Contact Marta Rola (+351 934742214, marta.rola@chsj.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy of donated human milk (time frame: At baseline before pasteurization; at baseline after pasteurization.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.