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Extreme Preterm Nutrition Study
DOI 10.1186/ISRCTN19509258
ClinicalTrials.gov identifier
EudraCT number
Public title Extreme Preterm Nutrition Study
Scientific title
Acronym ExPN study
Serial number at source LWH0502
Study hypothesis Will better nutrition improve head growth and neurodevelopmental outcome in very preterm infants?
Lay summary
Ethics approval Ethics approval received from Liverpool Children's Research Ethics Committee on 29th September 2003 (ref: 03/08/141/C).
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Extreme prematurity
Participants - inclusion criteria Babies (singletons/twins) born less than 29 completed weeks gestation, but at least 24 weeks gestation and above
Participants - exclusion criteria Babies born with major congenital malformations, triplets and other higher multiple births
Anticipated start date 26/01/2004
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 140
Interventions Hyperalimentation - providing 20% more calories in total parenteral nutrition followed by 20% more protein in enteral feeds, from birth to 34 weeks corrected gestational age
Control: usual care
Primary outcome measure(s) Head circumference at 36 weeks corrected gestational age
Secondary outcome measure(s) 1. Quantitative cranial Magnetic Resonance Imaging (MRI) analysis at 40 weeks corrected gestational age
2. Neurodevelopmental assessment using Bayley's Scales of Infant Development II (BSID-II) at three months and nine months post-term
Sources of funding 'Own account', fully funded by Liverpool Women's NHS R&D support funds (UK)
Trial website
Publications Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/18252814 (neonatal outcomes)
2. http://www.ncbi.nlm.nih.gov/pubmed/18285378 (MRI and developmental outcomes)
Contact name Prof  Richard  Cooke
  Address Neonatal Unit
Liverpool Women's Hospital
Crown Street
  City/town Liverpool
  Zip/Postcode L8 7SS
  Country United Kingdom
  Tel +44 (0)151 708 9988
  Fax +44 (0)151 702 4024
  Email mc19@liv.ac.uk
Sponsor Liverpool Women's NHS Foundation Trust (UK)
  Address Crown Street
  City/town Liverpool
  Zip/Postcode L8 7SS
  Country United Kingdom
  Tel +44 (0)151 708 9988
  Fax +44 (0)151 702 4024
  Email lynne.webster@lwh.nhs.uk
Date applied 08/09/2005
Last edited 01/09/2008
Date ISRCTN assigned 16/02/2006
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