Determinants of the Nutritional Composition of Donor Human Milk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Human Milk Nutrition. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of Determinants of the Nutritional Composition of Donor Human Milk
Overview
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).
Primary outcome measures
- Energy of donated human milk [Time frame: At baseline before pasteurization; at baseline after pasteurization.]
- Total protein levels of donated human milk [Time frame: At baseline before pasteurization; at baseline after pasteurization.]
- True protein levels of donated human milk [Time frame: At baseline before pasteurization; at baseline after pasteurization.]
- Fat levels of donated human milk [Time frame: At baseline before pasteurization; at baseline after pasteurization.]
- Carbohydrates levels of donated human milk [Time frame: At baseline before pasteurization; at baseline after pasteurization.]
- Body mass index of the donor [Time frame: At baseline]
- Gestational weight gain of the donor [Time frame: At baseline]
- Waist circunference of the donor. [Time frame: At baseline]
- Hip circunference of the donor [Time frame: At baseline]
- Assessment of the donors' eating habits [Time frame: At baseline]
Eligibility criteria
Inclusion criteria
- Human milk donors at BLHN
- Informed consent of the participant
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Portugal · 1 center
- Centro Hospitalar Universitário São João (CHUSJ) — Porto
Identifiers
NCT: NCT06904924 · BLHN/ Pediatric Nutrition