An observational study in Human Milk Nutrition, sponsored by Universidade do Porto. Not yet recruiting at 1 site in Portugal. Open to female participants. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Universidade do Porto · Observational
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:
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).
Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Human milk donors from BLHN
Exclusion Criteria:
Mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.
Energy of donated human milk
Determination of the energy composition of the donated human milk (kcal/100mL).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At baseline before pasteurization; at baseline after pasteurization.
Carbohydrates levels of donated human milk
Determination of carbohydrates levels of donated human milk (g/100mL).
Time frame: 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).
Time frame: At baseline
Gestational weight gain of the donor
Gestational weight gain (kg) by the donor.
Time frame: At baseline
Waist circunference of the donor.
Waist circunference (cm) of the donor.
Time frame: At baseline
Hip circunference of the donor
Hip circunference (cm) of the donor.
Time frame: 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.
Time frame: At baseline
Plan to share: Undecided
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Universidade do Porto