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

NCT04400396 | Unknown

• 1 other identifier: CHULC.CI512.2020
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• adiposity (fat mass index)

  ratio of fat mass over squared body length

  A single measurement performed up to 10 days after home discharge

Secondary Outcomes (1)

• adiposity (fat mass percentage)

  A single measurement performed up to 10 days after home discharge

Study Arms (2)

target HM fortification

Contemporary cohort fed HM with target fortification

Dietary Supplement: target HM fortification

standard HM fortification

Historical cohort fed HM with standard fortification

Dietary Supplement: standard HM fortification

Interventions

standard HM fortification DIETARY_SUPPLEMENT

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.

standard HM fortification

target HM fortification DIETARY_SUPPLEMENT

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)

target HM fortification

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Very preterm newborn infants (born at \<33 weeks) that achieve full enteral feeding exclusively or predominantly with human milk

You may qualify if:

• newborn infants born at \<33 weeks of gestation,
• admitted to the NICU of Maternidade Dr. Alfredo da Costa (inborns and outborns),
• exclusively or predominantly HM fed (\>87.5% volume per day)
• discharged alive.

You may not qualify if:

• multiples of grade \>2
• diagnosis of innate metabolism disorder,
• fed with formula for \>12.5% of the daily volume intake for two or more consecutive full days ,
• discharge with transference to other hospital,
• unavailable for body composition analysis after discharge.

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead
• Sociedade Portuguesa de Neonatologia: collaborator

Study Sites (1)

Centro Hospitalar Universitário de Lisboa Central

Lisbon, 1150-199, Portugal

Location

Related Publications (9)

• Macedo I, Pereira-da-Silva L, Cardoso M. The fortification method relying on assumed human milk composition overestimates the actual energy and macronutrient intakes in very preterm infants. Matern Health Neonatol Perinatol. 2018 Sep 17;4:22. doi: 10.1186/s40748-018-0090-4. eCollection 2018.

  PMID: 30237896 BACKGROUND

• McLeod G, Sherriff J, Hartmann PE, Nathan E, Geddes D, Simmer K. Comparing different methods of human breast milk fortification using measured v. assumed macronutrient composition to target reference growth: a randomised controlled trial. Br J Nutr. 2016 Feb 14;115(3):431-9. doi: 10.1017/S0007114515004614. Epub 2015 Dec 2.

  PMID: 26627899 BACKGROUND

• Rochow N, Landau-Crangle E, Fusch C. Challenges in breast milk fortification for preterm infants. Curr Opin Clin Nutr Metab Care. 2015 May;18(3):276-84. doi: 10.1097/MCO.0000000000000167.

  PMID: 25807355 BACKGROUND

• Macedo I, Pereira-da-Silva L, Cardoso M. Associations of Measured Protein and Energy Intakes with Growth and Adiposity in Human Milk-Fed Preterm Infants at Term Postmenstrual Age: A Cohort Study. Am J Perinatol. 2018 Jul;35(9):882-891. doi: 10.1055/s-0038-1626717. Epub 2018 Feb 2.

  PMID: 29532450 RESULT

• Henriksen C, Westerberg AC, Ronnestad A, Nakstad B, Veierod MB, Drevon CA, Iversen PO. Growth and nutrient intake among very-low-birth-weight infants fed fortified human milk during hospitalisation. Br J Nutr. 2009 Oct;102(8):1179-86. doi: 10.1017/S0007114509371755. Epub 2009 May 18.

  PMID: 19445820 RESULT

• Maas C, Wiechers C, Bernhard W, Poets CF, Franz AR. Early feeding of fortified breast milk and in-hospital-growth in very premature infants: a retrospective cohort analysis. BMC Pediatr. 2013 Nov 4;13:178. doi: 10.1186/1471-2431-13-178.

  PMID: 24180239 RESULT

• Morlacchi L, Mallardi D, Gianni ML, Roggero P, Amato O, Piemontese P, Consonni D, Mosca F. Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. J Transl Med. 2016 Jul 1;14(1):195. doi: 10.1186/s12967-016-0957-y.

  PMID: 27370649 RESULT

• Polberger S. New approaches to optimizing early diets. Nestle Nutr Workshop Ser Pediatr Program. 2009;63:195-204; discussion 204-8, 259-68. doi: 10.1159/000209982.

  PMID: 19346777 RESULT

• Cardoso M, Virella D, Macedo I, Silva D, Pereira-da-Silva L. Customized Human Milk Fortification Based on Measured Human Milk Composition to Improve the Quality of Growth in Very Preterm Infants: A Mixed-Cohort Study Protocol. Int J Environ Res Public Health. 2021 Jan 19;18(2):823. doi: 10.3390/ijerph18020823.

  PMID: 33477964 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human milk (HM), including mother's own milk (MOM) and donor's milk (DHM).

MeSH Terms

Conditions

Premature Birth; Breast Milk Expression; Feeding Behavior; Obesity

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Feeding; Behavior; Behavior, Animal; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Pereira-da-Silva, MD, PhD

  Universidade Nova de Lisboa

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 22, 2020
• Study Start: February 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 16, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

PT (1)