| - candidate number | 2442 |
| - NTR Number | NTR884 |
| - ISRCTN | ISRCTN16211826 |
| - Date ISRCTN created | 8-feb-2007 |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 1-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study. |
| - Scientific Title | Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study. |
| - ACRONYM | CARROT 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 VLBW infants. |
| - Healt Condition(s) or Problem(s) studied | Preterm infants, Prebiotics, Immune effects, Gastrointestinal tract |
| - Inclusion criteria | Infants born with a gestational age of less than 32 weeks and/ or a birthweight of less than 1500 gram |
| - Exclusion criteria | 1. Severe congenital disorders, like cardiac disorders, syndromal disorders, immunodeficiency disorders; 2. Congenital disorders of the gastrointestinal tract. |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Factorial |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-apr-2007 |
| - planned closingdate | 1-apr-2010 |
| - Target number of participants | 108 |
| - Interventions | Enteral 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 outcome | 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 prospecitively documented from birth till discharge home. |
| - Secondary outcome | 1. 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 | |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Dr. Ruurd M. Elburg van |
| - CONTACT for SCIENTIFIC QUERIES | Dr. 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. |
| - Publications | Westerbeek 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 summary | This 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) | |
| - RECORD | 1-feb-2007 - 9-feb-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl