Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.

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dc.contributor.authorBelfort MB
dc.contributor.authorCherkerzian S
dc.contributor.authorPepin H
dc.contributor.authorEllard D
dc.contributor.authorSteele T
dc.contributor.authorFusch C
dc.contributor.authorGrant PE
dc.contributor.authorInder TE
dc.contributor.authorWoodward, Lianne
dc.date.accessioned2021-07-07T22:20:22Z
dc.date.available2021-07-07T22:20:22Z
dc.date.issued2021en
dc.date.updated2021-04-23T01:41:56Z
dc.description.abstractHuman 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.<h4>Methods</h4>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.<h4>Discussion</h4>We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU).<h4>Trial registration</h4>NCT03977259 , registered 6 June, 2019.en
dc.identifier.citationBelfort 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-.en
dc.identifier.doihttp://doi.org/10.1186/s12887-021-02635-x
dc.identifier.issn1471-2431
dc.identifier.urihttps://hdl.handle.net/10092/102192
dc.languageeng
dc.language.isoen
dc.publisherSpringer Science and Business Media LLCen
dc.rightsAll rights reserved unless otherwise stateden
dc.rights.urihttp://hdl.handle.net/10092/17651en
dc.subjectGrowthen
dc.subjectHuman milken
dc.subjectMagnetic resonance imagingen
dc.subjectNeonatal intensive careen
dc.subjectNeurodevelopmenten
dc.subjectNutritionen
dc.subjectRandomized trialen
dc.subjectVery preterm infanten
dc.subject.anzsrcFields of Research::32 - Biomedical and clinical sciences::3213 - Paediatrics::321303 - Neonatologyen
dc.subject.anzsrcFields of Research::32 - Biomedical and clinical sciences::3210 - Nutrition and dietetics::321001 - Clinical nutritionen
dc.titleTargeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.en
dc.typeJournal Articleen
uc.collegeFaculty of Health
uc.departmentSchool of Health Sciences
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