Christoph Härtel1, Julia Pagel2, Jan Rupp3, Meike Bendiks2, Florian Guthmann4, Esther Rieger-Fackeldey5, Matthias Heckmann6, Axel Franz7, Jan-Holger Schiffmann8, Beate Zimmermann9, Nico Hepping2, Axel von der Wense10, Christian Wieg11, Egbert Herting2, Wolfgang Göpel2. 1. Department of Pediatrics, University at Lübeck, Lübeck, Germany. Electronic address: christoph.haertel@uksh.de. 2. Department of Pediatrics, University at Lübeck, Lübeck, Germany. 3. Institute for Medical Microbiology and Hygiene of the University at Lübeck, Lübeck, Germany. 4. Department of Neonatology, University of Tübingen, Tübingen, Germany. 5. Children's Hospitals Hannover Auf der Bult, Hannover, Germany. 6. Department of Pediatrics at University of Münster, Münster, Germany. 7. Department of Pediatrics, University of Greifswald, Greifswald, Germany. 8. Children's Hospital (Städtisches Klinikum) Nürmberg, Nürnberg, Germany. 9. Department of Pediatrics, GFO Hospitals Bonn, St. Marien Hospital, Bonn, Germany. 10. Department of Neonatology, Children's Hospital Hamburg-Altona, Hamburg-Altona, Germany. 11. Department of Neonatology and Pediatric Intensive Care, Klinikum Aschaffenburg, Aschaffenburg, Germany.
Abstract
OBJECTIVE: To evaluate outcome data in an observational cohort of very low birth weight infants of the German Neonatal Network stratified to prophylactic use of Lactobacillus acidophilus/Bifidobacterium infantis probiotics. STUDY DESIGN: Within the observational period (September 1, 2010, until December 31, 2012, n=5351 infants) study centers were categorized into 3 groups based on their choice of Lactobacillus acidophilus/Bifidobacterium infantis use: (1) no prophylactic use (12 centers); (2 a/b) change of strategy nonuser to user during observational period (13 centers); and (3) use before start of observation (21 centers). Primary outcome data of all eligible infants were determined according to center-specific strategy. RESULTS: The use of probiotics was associated with a reduced risk for necrotizing enterocolitis surgery (group 1 vs group 3: 4.2 vs 2.6%, P=.028; change of strategy: 6.2 vs 4.0%, P<.001), any abdominal surgery, and hospital mortality. Infants treated with probiotics had improved weight gain/day, and probiotics had no effect on the risk of blood-culture confirmed sepsis. In a multivariable logistic regression analysis, probiotics were protective for necrotizing enterocolitis surgery (OR 0.58, 95% CI 0.37-0.91; P=.017), any abdominal surgery (OR 0.7, 95% CI 0.51-0.95; P=.02), and the combined outcome abdominal surgery and/or death (OR 0.43; 95% CI 0.33-0.56; P<.001). CONCLUSIONS: Our observational data support the use of Lactobacillus acidophilus/Bifidobacterium infantis probiotics to reduce the risk for gastrointestinal morbidity but not sepsis in very low birth weight infants.
OBJECTIVE: To evaluate outcome data in an observational cohort of very low birth weight infants of the German Neonatal Network stratified to prophylactic use of Lactobacillus acidophilus/Bifidobacterium infantis probiotics. STUDY DESIGN: Within the observational period (September 1, 2010, until December 31, 2012, n=5351 infants) study centers were categorized into 3 groups based on their choice of Lactobacillus acidophilus/Bifidobacterium infantis use: (1) no prophylactic use (12 centers); (2 a/b) change of strategy nonuser to user during observational period (13 centers); and (3) use before start of observation (21 centers). Primary outcome data of all eligible infants were determined according to center-specific strategy. RESULTS: The use of probiotics was associated with a reduced risk for necrotizing enterocolitis surgery (group 1 vs group 3: 4.2 vs 2.6%, P=.028; change of strategy: 6.2 vs 4.0%, P<.001), any abdominal surgery, and hospital mortality. Infants treated with probiotics had improved weight gain/day, and probiotics had no effect on the risk of blood-culture confirmed sepsis. In a multivariable logistic regression analysis, probiotics were protective for necrotizing enterocolitis surgery (OR 0.58, 95% CI 0.37-0.91; P=.017), any abdominal surgery (OR 0.7, 95% CI 0.51-0.95; P=.02), and the combined outcome abdominal surgery and/or death (OR 0.43; 95% CI 0.33-0.56; P<.001). CONCLUSIONS: Our observational data support the use of Lactobacillus acidophilus/Bifidobacterium infantis probiotics to reduce the risk for gastrointestinal morbidity but not sepsis in very low birth weight infants.