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Type: Journal article
Title: The ProVIDe study: the impact of protein intravenous nutrition on development in extremely low birthweight babies
Author: Bloomfield, F.
Crowther, C.
Harding, J.
Conlon, C.
Jiang, Y.
Cormack, B.
Citation: BMC Pediatrics, 2015; 15(1):100-1-100-7
Publisher: BioMed Central
Issue Date: 2015
ISSN: 1471-2431
Statement of
Frank H. Bloomfield, Caroline A. Crowther, Jane E. Harding, Cathryn A. Conlon, Yannan Jiang and Barbara E. Cormack
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 protein in the first 5 days after birth will improve neurodevelopmental outcomes and growth in extremely low birthweight babies. METHODS/DESIGN: 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. PRIMARY OUTCOME: 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. SECONDARY OUTCOMES: 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. DISCUSSION: 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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12612001084875.
Keywords: Preterm infant; Nutrition; Growth; Protein; Neurodevelopment
Rights: © 2015 Bloomfield et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
DOI: 10.1186/s12887-015-0411-y
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