Immune effects of acidic and neutral oligosaccharides in the nutrition of preterm infants: CARROT study
| ISRCTN | ISRCTN16211826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16211826 |
| Protocol serial number | NTR884 |
| Sponsor | VU University Medical Centre (VUMC) (Netherlands) |
| Funder | Numico Research B.V. (Netherlands) |
- 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
Scientific
VU University Medical Centre
Department of Pediatrics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2413 |
|---|---|
| rm.vanelburg@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled factorial double-blinded trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. The effect of acidic and neutral oligosaccharides supplemented enteral feeding on infectious morbidity |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 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
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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 | |
| Protocol article | protocol | 23/10/2008 | Yes | No |
