http://pediatrics.aappublications.org/cgi/content/abstract/92/6/755


PEDIATRICS Vol. 92 No. 6 December 1993, pp. 755-760


Randomized Trial of Silver Nitrate, Erythromycin, and No Eye Prophylaxis for
the Prevention of Conjunctivitis Among Newborns Not at Risk for Gonococcal
Ophthalmitis

Thomas A. Bell MD, MPH1, J. Thomas Grayston MD2, Marijane A. Krohn PhD3,
Richard A. Kronmal PhD4, and The Eye Prophylaxis Study Group
1 From the Departments of Epidemiology, Pediatrics, University of
Washington, Seattle
2 From the Departments of Epidemiology, Pathobiology, University of
Washington, Seattle
3 From the Departments of Epidemiology, Obstetrics and Gynecology,
University of Washington, Seattle
4 From the Department of Biostatistics, University of Washington, Seattle
Objective. To compare the efficacy of commonly used forms of eye prophylaxis
for newborns with no prophylaxis in the prevention of nongonococcal
conjunctivitis.

Design. Randomized doubly masked clinical trial.

Setting. University of Washington Hospital and affiliated clinics, Seattle,
between 1985 and 1990.

Subjects. The medical records of 8499 women were evaluated for possible
participation; 2577 were eligible. Of the 758 enrolled, the infants of 630
were evaluable.

Intervention. Comparison of silver nitrate, erythromycin, and no eye
prophylaxis given at birth for the prevention of conjunctivitis.

Main outcome measures. Conjunctivitis during the first 60 days of life and
nasolacrimal duct patency in the first 2 days of life.

Results. The frequency of impatent tear ducts at the 30- to 48-hour
examination did not differ significantly by prophylaxis group. Among the 630
infants randomized and observed, 109 (17%) developed mild conjunctivitis.
Sixty-nine (63%) of the cases appeared during the first 2 weeks of life.
After 2 months of observation, infants allocated to silver nitrate eye
prophylaxis at birth had a 39% lower rate of conjunctivitis (hazard ratio =
0.61, 95% confidence interval = 0.39 to 0.97), and those allocated to
erythromycin had a 31% lower rate of conjunctivitis (hazaid ratio = 0.69,
95% confidence interval = 0.44 to 1.07), than did those allocated to no
prophylaxis.

Conclusion. Silver nitrate eye prophylaxis caused no sustained deleterious
effects and even provided some benefit to infants born to women without
Neisseria gonorrhoeae. However, the effect was modest and against
microorganisms of low virulence. The results suggest that parental choice of
a prophylaxis agent including no prophylaxis is reasonable for women
receiving prenatal care and who are screened for sexually transmitted
diseases during pregnancy.

Key Words: eye prophylaxis € infants € conjunctivitis € ophthalmia
neonatorum € silver nitrate € erythromycin

Submitted on November 23, 1992
Accepted on May 25, 1993



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