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Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study.


- candidate number2442
- NTR NumberNTR884
- ISRCTNISRCTN16211826
- Date ISRCTN created8-feb-2007
- date ISRCTN requested7-feb-2007
- Date Registered NTR1-feb-2007
- Secondary IDsN/A 
- Public TitleImmune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study.
- Scientific TitleImmune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study.
- ACRONYMCARROT study
- hypothesisAcidic 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 VLBW infants.
- Healt Condition(s) or Problem(s) studiedPreterm infants, Prebiotics, Immune effects, Gastrointestinal tract
- Inclusion criteriaInfants born with a gestational age of less than 32 weeks and/ or a birthweight of less than 1500 gram
- Exclusion criteria1. Severe congenital disorders, like cardiac disorders, syndromal disorders, immunodeficiency disorders; 2. Congenital disorders of the gastrointestinal tract.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type-
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-apr-2010
- Target number of participants108
- InterventionsEnteral supplementation of acidic and neutral oligosaccharides (20%/80% mixture) in a maximum doze of 1.5g/kg/day during the first month of life.
- Primary outcome1. 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 prospecitively documented from birth till discharge home.
- Secondary outcome1. 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
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Ruurd M. Elburg van
- CONTACT for SCIENTIFIC QUERIESDr. Ruurd M. Elburg van
- Sponsor/Initiator VU University Medical Center, Department of Paediatrics and Neonatology
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsWesterbeek EAM, van den Berg A, Lafeber HN, Knol J, Fetter WPF, van Elburg RM. The intestinal bacterial colonisation in preterm infants: A review of the literature. Clin Nutr. 2006;25:361-368. van den Berg A, van Elburg RM, Westerbeek EAM, Twisk JWR, Fetter WPF. Glutamine-enriched enteral nutrition in very-low-birth-weight infants and effects on feeding tolerance and infectious morbidity: a randomized controlled trial. Am J Clin Nutr 2005;81:1397-1404. Fanaro S, Jelinek J, Stahl B, Boehm G, Kock R, Vigi V. Acidic oligosaccharides from pectin hydrolysate as new component for infant formulae: Effect on intestinal flora stool characteristics, and pH. J Pediatr Gastroenterol Nutr. 2005;41:186-190.
- Brief summaryThis double-blind randomised controlled trial is designed to investigate the effect of acidic and neutral oligosaccharides supplemented enteral nutrition on infectious morbidity, feeding tolerance and short-term outcome in VLBW infants. Furthermore, to elucidate the role of acidic oligosaccharide supplemented enteral nutrition in postnatal adaptation of the gut and modulation of the immune response.
- Main changes (audit trail)
- RECORD1-feb-2007 - 9-feb-2007


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