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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04400396
Other study ID # CHULC.CI512.2020
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date December 16, 2021

Study information

Verified date June 2020
Source Centro Hospitalar de Lisboa Central
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018). The target fortification, based on analysis of HM composition, is considered the gold-standard method (Rochow 2015, McLeod 2016). This observational mixed cohort study aims to assess if very preterm infants fed HM with target fortification have greater growth during hospital stay and better body composition at term post-menstrual age (PMA), than those fed HM with standard fortification.


Description:

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Study Design


Intervention

Dietary Supplement:
standard HM fortification
Based on the assumed energy and macronutrient composition of HM, the commercial multi-component HM fortifier was added, in order to compensate identified nutritional deficits.
target HM fortification
Based on the measured energy and macronutrient composition of HM, modular protein and fat supplements are added, in addition to the commercial multi-component HM fortifier, in order to correct identified specific nutritional deficits. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020)

Locations

Country Name City State
Portugal Centro Hospitalar Universitário de Lisboa Central Lisboa

Sponsors (2)

Lead Sponsor Collaborator
Centro Hospitalar de Lisboa Central Sociedade Portuguesa de Neonatologia

Country where clinical trial is conducted

Portugal, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary weight gain velocity rate average relative daily variation of body weight from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
Primary length velocity rate average relative weekly variation of body length from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
Primary head circumference velocity rate average relative weekly variation of head circumference from baseline (the first day of exclusive or predominantly feeding with fortified human milk) up to 40 weeks postmenstrual age or to home discharge, whatever comes first
Primary adiposity (fat mass index) ratio of fat mass over squared body length A single measurement performed up to 10 days after home discharge
Secondary adiposity (fat mass percentage) proportion of fat mass on total body mass A single measurement performed up to 10 days after home discharge
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