Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.
Type of content
Journal Article
UC permalink
Publisher's DOI/URI
Thesis discipline
Degree name
Publisher
Springer Science and Business Media LLC
Journal Title
Journal ISSN
Volume Title
Language
eng
Date
2021
Authors
Belfort MB
Cherkerzian S
Pepin H
Ellard D
Steele T
Fusch C
Grant PE
Inder TE
Woodward, Lianne
Abstract
Human milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care.
Methods
We designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks' gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks' postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks' PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years' corrected age.Discussion
We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU).Trial registration
NCT03977259 , registered 6 June, 2019.Description
Citation
Belfort MB, Woodward LJ, Cherkerzian S, Pepin H, Ellard D, Steele T, Fusch C, Grant PE, Inder TE (2021). Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.. BMC pediatrics. 21(1). 167-.
Keywords
Growth, Human milk, Magnetic resonance imaging, Neonatal intensive care, Neurodevelopment, Nutrition, Randomized trial, Very preterm infant
Ngā upoko tukutuku/Māori subject headings
ANZSRC fields of research
Fields of Research::32 - Biomedical and clinical sciences::3213 - Paediatrics::321303 - Neonatology
Fields of Research::32 - Biomedical and clinical sciences::3210 - Nutrition and dietetics::321001 - Clinical nutrition
Fields of Research::32 - Biomedical and clinical sciences::3210 - Nutrition and dietetics::321001 - Clinical nutrition
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