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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR884 |
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Date of registration:
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01/02/2007 |
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Primary sponsor: |
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Public title:
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Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study.
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Scientific title:
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Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study. - CARROT study |
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Date of first enrolment:
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1/4/2007 |
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Target sample size:
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108 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=884 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Factorial; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Ruurd M.
Elburg van |
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Address:
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VU University Medical Center
Dept of Pediatrics
PO Box 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+3120-4442413 |
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Email:
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rm.vanelburg@vumc.nl |
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Affiliation:
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Name:
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Ruurd M.
Elburg van |
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Address:
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VU University Medical Center
Dept of Pediatrics
PO Box 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+3120-4442413 |
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Email:
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rm.vanelburg@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Preterm infants, Prebiotics, Immune effects, Gastrointestinal tract
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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ISRCTN16211826
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N/A
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Source(s) of Monetary Support
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Danone Research B.V.
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