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

ISRCTN	ISRCTN16211826
DOI	https://doi.org/10.1186/ISRCTN16211826
Secondary identifying numbers	NTR884

Submission date: 08/02/2007
Registration date: 08/02/2007
Last edited: 06/05/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ruurd M van Elburg
Scientific

VU University Medical Centre
Department of Pediatrics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 2413
Email	rm.vanelburg@vumc.nl

Study information

Study design	Randomised placebo-controlled factorial double-blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	CARROT study
Study objectives	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(s)	Medical Ethics Committee VU Medical Centre, 15/02/2007
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2007
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target number of participants	108
Key inclusion criteria	Infants born with a gestational age of less than 32 weeks and/or a birthweight of less than 1500g
Key exclusion criteria	1. Severe congenital disorders, like cardiac disorders, syndromal disorders, immunodeficiency disorders 2. Congenital disorders of the gastrointestinal tract
Date of first enrolment	01/04/2007
Date of final enrolment	01/04/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Centre

Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

Department of Paediatrics and Neonatology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 444 4444
Email	w.fetter@vumc.nl
Website	http://www.vumc.nl/english/#http://www.vumc.nl/english/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Industry

Numico Research B.V. (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	23/10/2008	Yes	No
Results article	results	01/03/2010	Yes	No
Results article	external supplementation results	01/01/2011	Yes	No
Results article	results	08/08/2013	Yes	No