No registrations found.
ID
Source
Brief title
Health condition
Prebiotics, Immune effects, Gastrointestinal tract, preterm infants
Prebiotica, Immuunsysteem, Maagdarmkanaal, Tevroeggeboren kinderen
Sponsors and support
Intervention
Outcome measures
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
Background 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.
Study objective
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.
Intervention
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.
Dept of Pediatrics
PO Box 7057
Ruurd M. Elburg van
Amsterdam 1007 MB
The Netherlands
+3120-4442413
rm.vanelburg@vumc.nl
Dept of Pediatrics
PO Box 7057
Ruurd M. Elburg van
Amsterdam 1007 MB
The Netherlands
+3120-4442413
rm.vanelburg@vumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL870 |
| NTR-old | NTR884 |
| Other | : N/A |
| ISRCTN | ISRCTN16211826 |
Summary results
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.