BACKGROUND: There are no comparative data on the impact of different empiric antibiotic regimens on early bowel colonization as well as on clinical efficacy in extremely low-birthweight (ELBW) neonates at risk of early onset sepsis (EOS). METHODS: A subgroup analysis was carried out of ELBW neonates recruited into a two-center, prospective, cluster randomized study comparing ampicillin and penicillin both combined with gentamicin, within the first 72 h of life. A composite primary end-point (need for change of antibiotics within 72 h and/or 7 day all-cause mortality) and the rate and duration of colonization by opportunistic aerobic microorganisms were assessed using hierarchical models corrected for study center and period. RESULTS: In the ampicillin (n= 36) and penicillin (n= 39) groups change of antibiotics, 7 day mortality and the composite end-point occurred at similar rates. Neonatal intensive care unit mortality for infants with gestational age <26 weeks was lower in the ampicillin group. Ampicillin treatment was associated with a higher colonization rate by Klebsiella pneumoniae, including ampicillin-resistant strains. CONCLUSION: Preliminary data indicate an urgent need for adequately powered studies of early antibiotic therapy in the subpopulation of ELBW neonates at risk of EOS.
RCT Entities:
BACKGROUND: There are no comparative data on the impact of different empiric antibiotic regimens on early bowel colonization as well as on clinical efficacy in extremely low-birthweight (ELBW) neonates at risk of early onset sepsis (EOS). METHODS: A subgroup analysis was carried out of ELBW neonates recruited into a two-center, prospective, cluster randomized study comparing ampicillin and penicillin both combined with gentamicin, within the first 72 h of life. A composite primary end-point (need for change of antibiotics within 72 h and/or 7 day all-cause mortality) and the rate and duration of colonization by opportunistic aerobic microorganisms were assessed using hierarchical models corrected for study center and period. RESULTS: In the ampicillin (n= 36) and penicillin (n= 39) groups change of antibiotics, 7 day mortality and the composite end-point occurred at similar rates. Neonatal intensive care unit mortality for infants with gestational age <26 weeks was lower in the ampicillin group. Ampicillin treatment was associated with a higher colonization rate by Klebsiella pneumoniae, including ampicillin-resistant strains. CONCLUSION: Preliminary data indicate an urgent need for adequately powered studies of early antibiotic therapy in the subpopulation of ELBW neonates at risk of EOS.
Authors: Christoph P Hornik; Daniel K Benjamin; P Brian Smith; Michael J Pencina; Adriana H Tremoulet; Edmund V Capparelli; Jessica E Ericson; Reese H Clark; Michael Cohen-Wolkowiez Journal: J Pediatr Date: 2016-08-10 Impact factor: 6.314