Prematurity Clinical Trial
— TargetFortOfficial title:
Effect of Target vs. Standard Human Milk Fortification on the Growth and Body Composition of Predominantly Human Milk Fed Very Preterm Infants
Verified date | June 2020 |
Source | Centro Hospitalar de Lisboa Central |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | December 16, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Centro Hospitalar Universitário de Lisboa Central | Lisboa |
Lead Sponsor | Collaborator |
---|---|
Centro Hospitalar de Lisboa Central | Sociedade Portuguesa de Neonatologia |
Portugal,
Henriksen C, Westerberg AC, Rønnestad A, Nakstad B, Veierød 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/S000711 — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
Morlacchi L, Mallardi D, Giannì 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: — View Citation
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. — View Citation
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. Review. — View Citation
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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