PURPOSE: To evaluate the efficacy of povidone iodine solution 2.5% and tetracycline ointment 1% in prevention of ophthalmia neonatorum (ON). DESIGN: Prospective, randomized, controlled observational study. PARTICIPANTS: Three-hundred ninety-four full-term neonates. METHODS: A randomized comparison between 201 neonates randomly treated withpovidone iodine 2.5% solution and 193 treated with tetracycline 1% ointment. MAIN OUTCOMES MEASURES: Incidence of ON. RESULTS: The incidence of ON was significantly higher after povidone iodine than tetracycline prophylaxis (15.4% and 5.2% respectively; P = 0.001). Noninfective ON developed in 10 (5%) of the 201 neonates treated with povidone iodine and in none (0%) of the neonates treated with tetracycline (P = .002). Infective ON was detected in 21 (10.4%) of the neonates treated with povidone iodine and in 10 (5.2%) after treatment with tetracycline (P = .052). Ophthalmia neonatorum appeared more commonly in the first 3 days after treatment with povidone iodine (P = .043). The spectrum of the infective isolates was similar in the 2 groups. CONCLUSIONS: Povidone iodine was associated with noninfective (sterile) conjunctivitis, probably because of its toxicity to the ocular surface in neonates. Tetracycline was marginally more effective against infective ON. For these reasons, tetracycline, rather than povidone iodine, is recommended for prevention of ON.
RCT Entities:
PURPOSE: To evaluate the efficacy of povidone iodine solution 2.5% and tetracycline ointment 1% in prevention of ophthalmia neonatorum (ON). DESIGN: Prospective, randomized, controlled observational study. PARTICIPANTS: Three-hundred ninety-four full-term neonates. METHODS: A randomized comparison between 201 neonates randomly treated with povidone iodine 2.5% solution and 193 treated with tetracycline 1% ointment. MAIN OUTCOMES MEASURES: Incidence of ON. RESULTS: The incidence of ON was significantly higher after povidone iodine than tetracycline prophylaxis (15.4% and 5.2% respectively; P = 0.001). Noninfective ON developed in 10 (5%) of the 201 neonates treated with povidone iodine and in none (0%) of the neonates treated with tetracycline (P = .002). Infective ON was detected in 21 (10.4%) of the neonates treated with povidone iodine and in 10 (5.2%) after treatment with tetracycline (P = .052). Ophthalmia neonatorum appeared more commonly in the first 3 days after treatment with povidone iodine (P = .043). The spectrum of the infective isolates was similar in the 2 groups. CONCLUSIONS:Povidone iodine was associated with noninfective (sterile) conjunctivitis, probably because of its toxicity to the ocular surface in neonates. Tetracycline was marginally more effective against infective ON. For these reasons, tetracycline, rather than povidone iodine, is recommended for prevention of ON.
Authors: Tamar A Smith-Norowitz; Crystal Ukaegbu; Stephan Kohlhoff; Margaret R Hammerschlag Journal: BMC Infect Dis Date: 2021-03-17 Impact factor: 3.090