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The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age

Human milk fortification is a routine clinical practice for feeding preterm infants. We hypothesized that donkey milk can be a suitable basis for developing an innovative human milk fortifier. Our randomized controlled single-blind clinical trial, named “Fortilat”, evaluated the feeding tolerance, g...

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Autores principales: Peila, Chiara, Spada, Elena, Bertino, Enrico, Deantoni, Sonia, Percivati, Federica, Moro, Guido E., Giribaldi, Marzia, Cavallarin, Laura, Cresi, Francesco, Coscia, Alessandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7761645/
https://www.ncbi.nlm.nih.gov/pubmed/33287300
http://dx.doi.org/10.3390/nu12123730
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author Peila, Chiara
Spada, Elena
Bertino, Enrico
Deantoni, Sonia
Percivati, Federica
Moro, Guido E.
Giribaldi, Marzia
Cavallarin, Laura
Cresi, Francesco
Coscia, Alessandra
author_facet Peila, Chiara
Spada, Elena
Bertino, Enrico
Deantoni, Sonia
Percivati, Federica
Moro, Guido E.
Giribaldi, Marzia
Cavallarin, Laura
Cresi, Francesco
Coscia, Alessandra
author_sort Peila, Chiara
collection PubMed
description Human milk fortification is a routine clinical practice for feeding preterm infants. We hypothesized that donkey milk can be a suitable basis for developing an innovative human milk fortifier. Our randomized controlled single-blind clinical trial, named “Fortilat”, evaluated the feeding tolerance, growth and clinical short-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk. The aim of the current study is to extend the previous findings and to evaluate the auxological outcomes of the infants enrolled in the “Fortilat” trial at 18 months of age. In the previous trial “Fortilat”, the fortification protocol followed was the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. All infants enrolled in the trial were included in a premature infant developmental evaluation program consisting of hospital visits at 40 ± 1 weeks of postmenstrual age, and at 6, 12 and 18 months of corrected age. Weight, head circumference and length were expressed in z-score using neonatal Intergrowth21st and INeS charts at birth, and WHO 0–5 years growth charts at 18 months. 122 children (Bovine-arm = 62, Donkey-arm = 60) were included in this study. All the observations were recorded in the interval of 18 ± 3 months of the correct age. The two groups did not differ for head circumference, length or weight at 18 months of age. Our data show that fortifiers derived from donkey milk had not different long term auxological outcomes of standard bovine-derived fortifier, but the new donkey milk fortifier was well tolerated in our population.
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spelling pubmed-77616452020-12-26 The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age Peila, Chiara Spada, Elena Bertino, Enrico Deantoni, Sonia Percivati, Federica Moro, Guido E. Giribaldi, Marzia Cavallarin, Laura Cresi, Francesco Coscia, Alessandra Nutrients Article Human milk fortification is a routine clinical practice for feeding preterm infants. We hypothesized that donkey milk can be a suitable basis for developing an innovative human milk fortifier. Our randomized controlled single-blind clinical trial, named “Fortilat”, evaluated the feeding tolerance, growth and clinical short-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk. The aim of the current study is to extend the previous findings and to evaluate the auxological outcomes of the infants enrolled in the “Fortilat” trial at 18 months of age. In the previous trial “Fortilat”, the fortification protocol followed was the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. All infants enrolled in the trial were included in a premature infant developmental evaluation program consisting of hospital visits at 40 ± 1 weeks of postmenstrual age, and at 6, 12 and 18 months of corrected age. Weight, head circumference and length were expressed in z-score using neonatal Intergrowth21st and INeS charts at birth, and WHO 0–5 years growth charts at 18 months. 122 children (Bovine-arm = 62, Donkey-arm = 60) were included in this study. All the observations were recorded in the interval of 18 ± 3 months of the correct age. The two groups did not differ for head circumference, length or weight at 18 months of age. Our data show that fortifiers derived from donkey milk had not different long term auxological outcomes of standard bovine-derived fortifier, but the new donkey milk fortifier was well tolerated in our population. MDPI 2020-12-03 /pmc/articles/PMC7761645/ /pubmed/33287300 http://dx.doi.org/10.3390/nu12123730 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Peila, Chiara
Spada, Elena
Bertino, Enrico
Deantoni, Sonia
Percivati, Federica
Moro, Guido E.
Giribaldi, Marzia
Cavallarin, Laura
Cresi, Francesco
Coscia, Alessandra
The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age
title The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age
title_full The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age
title_fullStr The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age
title_full_unstemmed The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age
title_short The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age
title_sort “fortilat” randomized clinical trial follow-up: auxological outcome at 18 months of age
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7761645/
https://www.ncbi.nlm.nih.gov/pubmed/33287300
http://dx.doi.org/10.3390/nu12123730
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