Determinants of the Nutritional Composition of Donor Human Milk
ConditionHuman Milk Nutrition
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorUniversidade do Porto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Human milk donors at BLHN
Informed consent of the participant
Disqualifiers
None
Trial population
Human milk donors from BLHN
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 1 trial groupGroup A: Human milk donor
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade do Porto
Lead sponsor
Banco de Leite Humano do Norte
Collaborator
Centro Hospitalar De São João, E.P.E.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: