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Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study
ISRCTN ISRCTN16211826
DOI 10.1186/ISRCTN16211826
ClinicalTrials.gov identifier
EudraCT number
Public title Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study
Scientific title
Acronym CARROT study
Serial number at source NTR884
Study hypothesis Acidic and neutral oligosaccharides supplemented enteral nutrition has a positive effect on infectious morbidity, modulation of the immune response, postnatal adaptation of the gut, feeding tolerance and short-term outcome in Very Low Birth Weight (VLBW) infants.
2006 literature review on http://www.ncbi.nlm.nih.gov/pubmed/16677741.
Lay summary Not provided at time of registration
Ethics approval Medical Ethics Committee VU Medical Centre, 15/02/2007
Study design Randomised placebo-controlled factorial double-blinded trial
Countries of recruitment Netherlands
Disease/condition/study domain Prebiotics, gastrointestinal tract, preterm infants, immune effects
Participants - inclusion criteria Infants born with a gestational age of less than 32 weeks and/or a birthweight of less than 1500g
Participants - exclusion criteria 1. Severe congenital disorders, like cardiac disorders, syndromal disorders, immunodeficiency disorders
2. Congenital disorders of the gastrointestinal tract
Anticipated start date 01/04/2007
Anticipated end date 01/04/2010
Status of trial Completed
Patient information material
Target number of participants 108
Interventions Enteral supplementation of acidic and neutral oligosaccharides (20%/80% mixture) in a maximum dose of 1.5 g/kg/day during the first month of life.
Primary outcome measure(s) 1. The effect of acidic and neutral oligosaccharides supplemented enteral feeding on infectious morbidity
2. The incidence of serious infections, using the previously described criteria for serious infections in preterm infants at high risk for serious infections, are prospectively documented from birth until discharge home
Secondary outcome measure(s) The effect of acidic and neutral oligosaccharides supplemented enteral nutrition on feeding tolerance, short-term outcome, postnatal adaptation of the gut and modulation of the immune response
Sources of funding Numico Research B.V. (Netherlands)
Trial website
Publications 1. 2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18947426
2. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/20032496
3. 2011 external supplementation results in: http://www.ncbi.nlm.nih.gov/pubmed/20863418
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23951035
Contact name Dr  Ruurd M  van Elburg
  Address VU University Medical Centre
Department of Pediatrics
P.O. Box 7057
  City/town Amsterdam
  Zip/Postcode 1007 MB
  Country Netherlands
  Tel +31 (0)20 444 2413
  Fax +31 (0)20 444 3045
  Email rm.vanelburg@vumc.nl
Sponsor VU University Medical Centre (VUMC) (Netherlands)
  Address Department of Paediatrics and Neonatology
De Boelelaan 1117
  City/town Amsterdam
  Zip/Postcode 1081 HV
  Country Netherlands
  Tel +31 (0)20 444 4444
  Fax +31 (0)20 444 4645
  Email w.fetter@vumc.nl
  Sponsor website: http://www.vumc.nl/english/#http://www.vumc.nl/english/
Date applied 08/02/2007
Last edited 06/05/2014
Date ISRCTN assigned 08/02/2007
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