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Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)

NCT04400396 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-06-09

No results posted yet for this study

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.

Conditions

  • Growth
  • Body Composition
  • Prematurity
  • Breast Milk Collection
  • Nutrient Deficiency
  • Feeding Patterns
  • Adiposity

Interventions

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.

DIETARY_SUPPLEMENT

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)

Sponsors & Collaborators

  • Sociedade Portuguesa de Neonatologia

    collaborator UNKNOWN

  • Centro Hospitalar de Lisboa Central

    lead OTHER

Principal Investigators

  • Luis Pereira-da-Silva, MD, PhD · Universidade Nova de Lisboa

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-06-30
Completion
2021-12-16

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 NCT04400396 on ClinicalTrials.gov