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The effect on clinical outcome of glutamine supplementation of parenteral nutrition in the surgical newborn infant
DOI 10.1186/ISRCTN83168963
ClinicalTrials.gov identifier
EudraCT number
Public title The effect on clinical outcome of glutamine supplementation of parenteral nutrition in the surgical newborn infant
Scientific title
Acronym SIGN (Surgical Infants Glutamine Nutrition)
Serial number at source SP3763
Study hypothesis We will test the hypothesis that glutamine supplementation in the parenteral nutrition (PN) of surgical infants determines more rapid recovery of intestinal function and reduction in infection rate.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from local medical ethics committee (ref: 2/4/002).
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Surgical newborn infants on parenteral nutrition
Participants - inclusion criteria 1. Surgical infants below the age of 3 months, either sex
2. Require parenteral nutrition
3. Have received less than 5 days of parenteral nutrition already
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/04/2002
Anticipated end date 30/09/2004
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 250
Interventions The treatment group will receive glutamine-supplemented parenteral nutrition.
The control group will receive isonitrogenous parenteral nutrition.

All patients will have data collected once a week on clinical state, feeding, liver and renal function tests, ammonia, septic episodes and parenteral nutrition lines
Primary outcome measure(s) 1. Infection: episodes of sepsis and septicaemia, timing of sepsis and septicaemia
2. Intestinal function: time to full enteral feeding and time on (days)
Secondary outcome measure(s) 1. Growth
2. Nutrient intake
3. Biochemical measures of hepatic function
Sources of funding Action Medical Research (UK)
Trial website http://www.ich.ucl.ac.uk/ich/html/academicunits/surgery/sign2/signindex.html
Publications 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22513659
Contact name Dr  Agostino  Pierro
  Address Paediatric Surgery Unit
Institute of Child Health
30 Guilford Street
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Tel +44 (0)20 7272 2814
  Fax +44 (0)20 7404 6181
  Email SIGN.Trial@ich.ucl.ac.uk
Sponsor Action Medical Research (UK)
  Address Vincent House
  City/town Horsham West Sussex
  Zip/Postcode RH12 2DP
  Country United Kingdom
  Tel +44 (0)1403 210 406
  Fax +44 (0)1403 210 541
  Email info@actionresearch.co.uk
  Sponsor website: http://www.action.org.uk/
Date applied 30/04/2003
Last edited 09/10/2014
Date ISRCTN assigned 30/04/2003
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