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Determinants of the Nutritional Composition of Donor Human Milk

NCT06904924 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

  • Human Milk Nutrition

Sponsors & Collaborators

  • Banco de Leite Humano do Norte

    collaborator UNKNOWN

  • Centro Hospitalar De São João, E.P.E.

    collaborator OTHER

  • Faculdade de Medicina da Universidade do Porto - CINTESIS

    collaborator UNKNOWN

  • Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto (FCNAUP)

    collaborator UNKNOWN

  • Universidade do Porto

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06904924 on ClinicalTrials.gov