Neutral and acidic oligosaccharides in preterm infants: a randomized, double-blind, placebo-controlled trial1234

https://doi.org/10.3945/ajcn.2009.28625Get rights and content
Under an Elsevier user license
open archive

Background: Serious infectious morbidity is high in preterm infants. Enteral supplementation of prebiotics may reduce the incidence of serious infections, especially infections related to the gastrointestinal tract.

Objective: The objective was to determine the effect of enteral supplementation of a prebiotic mixture consisting of neutral oligosaccharides (SCGOS/LCFOS) and acidic oligosaccharides (AOS) on serious infectious morbidity in preterm infants.

Design: In a randomized controlled trial, preterm infants (gestational age <32 wk and/or birth weight <1500 g) received enteral supplementation of 80% SCGOS/LCFOS and 20% AOS (1.5 g · kg−1 · d−1) or placebo (maltodextrin) between days 3 and 30 of life. Serious infectious morbidity was defined as a culture positive for sepsis, meningitis, pyelonephritis, or pneumonia. The analysis was performed by intention-to-treat and per-protocol, defined as ≥50% supplementation dose during the study period.

Results: In total, 113 preterm infants were included. Baseline and nutritional characteristics were not different between groups. In the intention-to-treat analysis, the incidence of ≥1 serious infection, ≥1 serious endogenous infection, or ≥2 serious infectious episodes was not significantly different in the SCGOS/LCFOS/AOS-supplemented and placebo groups. In the per-protocol analysis, there was a trend toward a lower incidence of ≥1 serious endogenous infection and ≥2 serious infectious episodes in the SCGOS/LCFOS/AOS-supplemented group than in the placebo group (P = 0.09 and P = 0.07, respectively).

Conclusions: Enteral supplementation of SCGOS/LCFOS/AOS does not significantly reduce the risk of serious infectious morbidity in preterm infants. However, there was a trend toward a lower incidence of serious infectious morbidity, especially for infections with endogenous bacteria. This finding suggests a possible beneficial effect that should be evaluated in a larger study. This trial was registered at isrctn.org as ISRCTN16211826.

Cited by (0)

1

From the Department of Pediatrics, Division of Neonatology, VU University Medical Center, Amsterdam, Netherlands (EAMW, JPvdB, HNL, WPFF, and RMvE); Sophia Children Hospital, Erasmus University, Rotterdam, Netherlands (GB); Danone Research, Friedrichsdorf, Germany (GB); and the Institute of Research in Extramural Medicine, VU University Medical Center, Amsterdam, Netherlands (JWRT).

2

The funding source had no involvement in the analysis of the data or inthe interpretation of the results.

3

Supported by Danone Research, Friedrichsdorf, Germany. Danone Research provided the preterm formula (Nenatal Start) and postdischarge formula (Nenatal 1), neutral and acidic oligosaccharides and placebo supplementation.

4

Address correspondence to RM van Elburg, Department of Pediatrics, Subdivision of Neonatology, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, Netherlands. E-mail: [email protected].