RANDOMIZED TRIAL OF SILVER-NITRATE, ERYTHROMYCIN, AND NO EYE PROPHYLAXIS FOR THE PREVENTION OF CONJUNCTIVITIS AMONG NEWBORNS NOT AT RISK FOR GONOCOCCAL OPHTHALMITIS

Objective. To compare the efficacy of commonly used forms of eye proph ylaxis for newborns with no prophylaxis in the prevention of nongonoco ccal conjunctivitis. Design. Randomized doubly masked clinical trial. Setting. University of Washington Hospital and affiliated clinics, Sea ttle, between 1985 and 1990. Subjects. The medical records of 8499 wom en were evaluated for possible participation; 2577 were eligible. Of t he 758 enrolled, the infants of 630 were evaluable. Intervention. Comp arison of silver nitrate, erythromycin, and no eye prophylaxis given a t birth for the prevention of conjunctivitis. Main outcome measures. C onjunctivitis during the first 60 days of life and nasolacrimal duct p atency in the first 2 days of life. Results. The frequency of impatent tear ducts at the 30- to 48-hour examination did not differ significa ntly by prophylaxis group. Among the 630 infants randomized and observ ed, 109 (17%) developed mild conjunctivitis. Sixty-nine (63%) of the c ases appeared during the first 2 weeks of life. After 2 months of obse rvation, infants allocated to silver nitrate eye prophylaxis at birth had a 39% lower rate of conjunctivitis (hazard ratio = 0.61, 95% confi dence interval = 0.39 to 0.97), and those allocated to erythromycin ha d a 31% lower rate of conjunctivitis (hazard ratio = 0.69, 95% confide nce interval = 0.44 to 1.07), than did those allocated to no prophylax is. Conclusion. Silver nitrate eye prophylaxis caused no sustained del eterious effects and even provided some benefit to infants born to wom en without Neisseria gonorrhoeae. However, the effect was modest and a gainst microorganisms of low virulence. The results suggest that paren tal choice of a prophylaxis agent including no prophylaxis is reasonab le for women receiving prenatal care and who are screened for sexually transmitted diseases during pregnancy.