Clinical trial NCT06904924: Determinants of the Nutritional Composition of Donor Human Milk
Official title: Study of Determinants of the Nutritional Composition of Donor Human Milk
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Human Milk Nutrition
Keywords: Donor human milk
Human milk nutrition
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Banco de Leite Humano do Norte
name: Centro Hospitalar De São João, E.P.E.
name: Faculdade de Medicina da Universidade do Porto - CINTESIS
name: Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto (FCNAUP)
First posted: 2025-04-01
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Human milk donors from BLHN

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* Human milk donors at BLHN
* Informed consent of the participant

Exclusion Criteria:

* None

Primary outcomes:
measure: Energy of donated human milk
timeFrame: At baseline before pasteurization; at baseline after pasteurization.
measure: Total protein levels of donated human milk
timeFrame: At baseline before pasteurization; at baseline after pasteurization.
measure: True protein levels of donated human milk
timeFrame: At baseline before pasteurization; at baseline after pasteurization.
measure: Fat levels of donated human milk
timeFrame: At baseline before pasteurization; at baseline after pasteurization.
measure: Carbohydrates levels of donated human milk
timeFrame: At baseline before pasteurization; at baseline after pasteurization.
measure: Body mass index of the donor
timeFrame: At baseline
measure: Gestational weight gain of the donor
timeFrame: At baseline
measure: Waist circunference of the donor.
timeFrame: At baseline
measure: Hip circunference of the donor
timeFrame: At baseline
measure: Assessment of the donors' eating habits
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário São João (CHUSJ)
Study officials:
References: