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• W3020341781 abstract "Abstract Objective We aim to assess the feasibility of a pragmatic randomized trial of antibiotics vs. no antibiotics in symptomatic premature infants after birth. Most premature infants are exposed to antibiotics after birth without evidence of benefit or harm for this practice. No study to date has attempted to randomize premature infants to antibiotics vs no antibiotics after birth. Study Design Infants <33 weeks’ gestation admitted to the University of Florida Neonatal Intensive Care Unit were assigned to one of three groups after birth: (A) high risk – antibiotics indicated (B) low risk – antibiotics not indicated (C) eligible for un-blinded randomization (no antibiotics vs antibiotics). The primary outcome is a composite of serious adverse events including (necrotizing enterocolitis, late onset sepsis, bronchopulmonary dysplasia, and death). Odds ratios (and 95% CI’s) were calculated to compare adverse event rates between the two randomized groups. Results 186 subjects were enrolled (98 infants and 88 mothers) were enrolled over a 2-year period. 56% of infants (n=55) were randomized; 48% of infants randomized to the no antibiotics arm were switched and received antibiotics within the first 48 hours after birth. Serious adverse events were not significantly different between the randomization arms. Conclusion This is the first prospective randomized trial of antibiotics vs no antibiotics after birth in symptomatic premature infants. The results of this trial establish a framework of feasibility for a larger multicentered trial that is needed to evaluate the risks and benefits of routine antibiotic exposure in premature infants." @default.
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• W3020341781 date "2020-04-22" @default.
• W3020341781 modified "2023-10-14" @default.
• W3020341781 title "Routine Early Antibiotic use in SymptOmatic preterm Neonates (REASON): a prospective randomized controlled trial" @default.
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• W3020341781 doi "https://doi.org/10.1101/2020.04.17.20069617" @default.
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