Neutral and acidic oligosaccharides in preterm infants: a randomized, double-blind, placebo-controlled trial.
What this study found
Enteral SC GOS/LC FOS/AOS did not significantly reduce serious infectious morbidity in preterm infants. In intention-to-treat analysis, 23 of 55 (42%) supplemented infants versus 31 of 58 (54%) placebo infants had at least 1 serious infection (P = 0.22), and 9 of 55 (16%) versus 17 of 58 (29%) had at least 1 serious endogenous infection (P = 0.10). Per protocol, 5 of 43 (12%) versus 14 of 51 (28%) had at least 1 serious endogenous infection (P = 0.045), and 2 of 43 (5%) versus 10 of 51 (20%) had at least 2 serious infectious episodes (P = 0.03). Mild bronchopulmonary dysplasia was less…
- Study & population
- Randomized, double-blind, placebo-controlled trial in very preterm or very low birth weight infants admitted to NICU sites in the Netherlands.
- Intervention
- The active regimen was an enteral prebiotic mixture of 80% short-chain galactooligosaccharides/long-chain fructooligosaccharides (SC GOS/LC FOS) and 20% acidic oligosaccharides (AOS), given at a maximum dose of 1.5 g/kg/day.
- Key limitation
- The primary endpoint was not statistically significant, and the study appears modest in size, which limits power for detecting clinically important differences.
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Open PDFOriginal abstract
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 ((SC)GOS/(LC)FOS) 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% (SC)GOS/(LC)FOS 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 > or =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 > or =1 serious infection, > or =1 serious endogenous infection, or > or =2 serious infectious episodes was not significantly different in the (SC)GOS/(LC)FOS/AOS-supplemented and placebo groups. In the per-protocol analysis, there was a trend toward a lower incidence of > or =1 serious endogenous infection and > or =2 serious infectious episodes in the (SC)GOS/(LC)FOS/AOS-supplemented group than in the placebo group (P = 0.09 and P = 0.07, respectively). CONCLUSIONS Enteral supplementation of (SC)GOS/(LC)FOS/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.