NCT06904924|Not Yet Recruiting
Determinants of the Nutritional Composition of Donor Human Milk
Study of Determinants of the Nutritional Composition of Donor Human Milk
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Study of Determinants of the Nutritional Composition of Donor Human Milk
Sponsor study identifier
observational
80
1 country
1
Study Start
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 2025
Actual (reported)April 1, 2025
Actual (reported)May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Energy of donated human milk
Determination of the energy composition of the donated human milk (kcal/100mL).
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).
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).
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).
At baseline before pasteurization; at baseline after pasteurization.
Carbohydrates levels of donated human milk
Determination of carbohydrates levels of donated human milk (g/100mL).
At baseline before pasteurization; at baseline after pasteurization.
Mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.
Human milk donors from BLHN
Centro Hospitalar Universitário São João (CHUSJ)
Porto, 4200-319, Portugal
Donor's human milk (DHM).
First Submitted
March 17, 2025
First Posted
April 1, 2025
Study Start
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2028
EstimatedBody 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).
At baseline
Gestational weight gain of the donor
Gestational weight gain (kg) by the donor.
At baseline
Waist circunference of the donor.
Waist circunference (cm) of the donor.
At baseline
Hip circunference of the donor
Hip circunference (cm) of the donor.
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.
At baseline
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 1, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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