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

Tina Steele¹  Hunter Pepin²  Deirdre Ellard²  Sara Cherkerzian³  Mandy B. Belfort³  Terrie E. Inder³  Christoph Fusch⁴  P. Ellen Grant⁵  Lianne J. Woodward⁶ 

[1] Department of Pediatric Newborn Medicine, Brigham and Women’s Hospital, 221 Longwood Avenue, BL-341, 02115, Boston, MA, USA;Department of Nursing, Brigham and Women’s Hospital, Boston, MA, USA;Department of Pediatric Newborn Medicine, Brigham and Women’s Hospital, 221 Longwood Avenue, BL-341, 02115, Boston, MA, USA;Department of Nutrition, Brigham and Women’s Hospital, Boston, MA, USA;Department of Pediatric Newborn Medicine, Brigham and Women’s Hospital, 221 Longwood Avenue, BL-341, 02115, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;Department of Pediatrics, Paracelsus Medical School, Nuremberg, Germany;Harvard Medical School, Boston, MA, USA;Division of Newborn Medicine, Boston Children’s Hospital, Boston, MA, USA;School of Health Sciences and Child Wellbeing Research Institute, University of Canterbury, Christchurch, New Zealand;

关键词: Human milk;    Nutrition;    Very preterm infant;    Neonatal intensive care;    Growth;    Neurodevelopment;    Magnetic resonance imaging;    Randomized trial;   

DOI  :  10.1186/s12887-021-02635-x

来源: Springer

【 摘 要 】

BackgroundHuman 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.MethodsWe 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.DiscussionWe expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU).Trial registrationNCT03977259, registered 6 June, 2019.

【 授权许可】

CC BY