title: The ProVIDe study: the impact of protein intravenous nutrition on development in extremely low birthweight babies.
abstract: BACKGROUND
  Preterm birth and very small size at birth have long-term effects on neurodevelopment and growth. A relatively small percentage of extremely low birthweight babies suffer from severe neurological disability; however, up to 50% experience some neurodevelopmental or learning disability in childhood. Current international consensus is that increased protein intake in the neonatal period improves both neurodevelopment and growth, but the quantum of protein required is not known. This trial aims to assess whether providing an extra 1 to 2 g.kg(-1).d(-1) protein in the first 5 days after birth will improve neurodevelopmental outcomes and growth in extremely low birthweight babies.
  
  
  METHODS
  The ProVIDe study is a multicentre, two-arm, double-blind, parallel, randomised, controlled trial. In addition to standard intravenous nutrition, 430 babies with a birthweight of less than 1000 g who have an umbilical arterial line in situ will be randomised in 1:1 ratio to receive either an amino acid solution (TrophAmine®) or placebo (saline) administered through the umbilical arterial catheter for the first 5 days. Exclusion criteria are admission to neonatal intensive care more than 24 h after birth; multiple births of more than 2 babies; known chromosomal or genetic abnormality, or congenital disorder affecting growth; inborn error of metabolism, and in danger of imminent death.
  
  
  METHODS
  Survival free from neurodevelopmental disability at 2 years' corrected age, where neurodevelopmental disability is defined as cerebral palsy, blindness, deafness, developmental delay (standardised score more than 1 SD below the mean on the cognitive, language or motor subscales of the Bayley Scales of Infant Development Edition 3), or Gross Motor Function Classification System score ≥ 1.
  
  
  RESULTS
  Growth, from birth to 36 weeks' corrected gestational age, at neonatal intensive care discharge and at 2 years' corrected age; body composition at 36 to 42 weeks' corrected postmenstrual age and at 2 years' corrected age; neonatal morbidity, including length of stay; nutritional intake.
  
  
  CONCLUSIONS
  This trial will provide the first direct evidence of the effects of giving preterm babies a higher intake of intravenous protein in the first week after birth on neurodevelopmental outcomes at 2 years corrected age.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12612001084875.
authors: Liggins Institute, The University of Auckland, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.|Newborn Services, Auckland City Hospital, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.|Gravida: National Centre for Growth and Development, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.|Auckland Academic Health Alliance, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.|Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.
authors: Frank H
authors: FH
authors: Bloomfield
authors: Liggins Institute, The University of Auckland, Auckland, New Zealand. c.crowther@auckland.ac.nz.|The Robinson Institute, The University of Adelaide, Adelaide, Australia. c.crowther@auckland.ac.nz.
authors: Caroline A
authors: CA
authors: Crowther
authors: Liggins Institute, The University of Auckland, Auckland, New Zealand. j.harding@auckland.ac.nz.
authors: Jane E
authors: JE
authors: Harding
authors: School of Food and Nutrition, College of Health, Massey University, Auckland, New Zealand. c.conlon@massey.ac.nz.
authors: Cathryn A
authors: CA
authors: Conlon
authors: Liggins Institute, The University of Auckland, Auckland, New Zealand. y.jiang@auckland.ac.nz.|Department of Statistics, Faculty of Science, The University of Auckland, Auckland, New Zealand. y.jiang@auckland.ac.nz.
authors: Yannan
authors: Y
authors: Jiang
authors: Liggins Institute, The University of Auckland, Auckland, New Zealand. bcormack@adhb.govt.nz.|Newborn Services, Auckland City Hospital, Auckland, New Zealand. bcormack@adhb.govt.nz.|Gravida: National Centre for Growth and Development, Auckland, New Zealand. bcormack@adhb.govt.nz.|Auckland Academic Health Alliance, Auckland, New Zealand. bcormack@adhb.govt.nz.
authors: Barbara E
authors: BE
authors: Cormack
mesh_terms: D001823:Body Composition; D002657:Child Development / Q000502:physiology; D002658:Developmental Disabilities / Q000517:prevention & control*; D004044:Dietary Proteins / Q000008:administration & dosage*; D004311:Double-Blind Method; D006130:Growth Disorders / Q000517:prevention & control; D006801:Humans; D052577:Infant, Extremely Low Birth Weight / Q000254:growth & development*; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay; D010288:Parenteral Nutrition / Q000379:methods*
chemical_list: D004044:Dietary Proteins