Contact information
Type
Scientific
Primary contact
Dr Ruurd M van Elburg
ORCID ID
Contact details
VU University Medical Centre
Department of Pediatrics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2413
rm.vanelburg@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR884
Study information
Scientific title
Acronym
CARROT study
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.
Ethics approval
Medical Ethics Committee VU Medical Centre, 15/02/2007
Study design
Randomised placebo-controlled factorial double-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Prebiotics, gastrointestinal tract, preterm infants, immune effects
Intervention
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.
Intervention type
Supplement
Phase
Not Specified
Drug names
Enteral supplementation of acidic and neutral oligosaccharides
Primary outcome measures
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 measures
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
Overall trial start date
01/04/2007
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Infants born with a gestational age of less than 32 weeks and/or a birthweight of less than 1500g
Participant type
Patient
Age group
Neonate
Gender
Not Specified
Target number of participants
108
Participant exclusion criteria
1. Severe congenital disorders, like cardiac disorders, syndromal disorders, immunodeficiency disorders
2. Congenital disorders of the gastrointestinal tract
Recruitment start date
01/04/2007
Recruitment end date
01/04/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Centre (VUMC) (Netherlands)
Sponsor details
Department of Paediatrics and Neonatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 4444
w.fetter@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Numico Research B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Protocol
Westerbeek EA, van Elburg RM, van den Berg A, van den Berg J, Twisk JW, Fetter WP, Lafeber HN, Design of a randomised controlled trial on immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: carrot study., BMC Pediatr, 2008, 8, 46, doi: 10.1186/1471-2431-8-46.
-
Results
Westerbeek EA, van den Berg JP, Lafeber HN, Fetter WP, Boehm G, Twisk JW, van Elburg RM, Neutral and acidic oligosaccharides in preterm infants: a randomized, double-blind, placebo-controlled trial., Am. J. Clin. Nutr., 2010, 91, 3, 679-686, doi: 10.3945/ajcn.2009.28625.
-
External supplementation results
Westerbeek EA, van den Berg A, Lafeber HN, Fetter WP, van Elburg RM, The effect of enteral supplementation of a prebiotic mixture of non-human milk galacto-, fructo- and acidic oligosaccharides on intestinal permeability in preterm infants., Br. J. Nutr., 2011, 105, 2, 268-274, doi: 10.1017/S0007114510003405.
-
Results
van den Berg JP, Westerbeek EA, van der Klis FR, Berbers GA, Lafeber HN, van Elburg RM, Neutral and acidic oligosaccharides supplementation does not increase the vaccine antibody response in preterm infants in a randomized clinical trial., PLoS ONE, 2013, 8, 8, e70904, doi: 10.1371/journal.pone.0070904.