SINGLE-DOSE PENICILLIN PROPHYLAXIS OF NEONATAL GROUP-B STREPTOCOCCAL DISEASE. Conclusion of a 41 Month Controlled Trial

The efficacy of a single dose of aqueous penicillin G in preventing neonatal group-B streptococcal infections was demonstrated in a randomised study conducted over 41 months. 16 082 infants received a single dose of penicillin within one hour of delivery, and 15 976 infants who received tetracycline ophthalmic ointment served as the control group. Group-B streptococcal systemic infections were significantly less common in the penicillin-treated infants (0·6 vs 1·7 cases per 1000 live births, p = 0·004). The incidence of infection caused by penicillin-resistant pathogens was insignificantly increased in the penicillin group (2·2 vs 1·6 cases per thousand live births, p = 0·32). This difference was accounted for almost completely by the events of the first 12 months of the study period when, for unexplained reasons, there was a considerable increase in the number of penicillin-resistant infections in the penicillin group (3·6 vs 1·4 cases per 1000 live births, p = 0·09). The mortality associated with penicillin-susceptible pathogens was higher in the control group (0·1 vs 0·4 per 1000 live births, p=0·18). However, the mortality associated with penicillin-resistant pathogens was increased in the penicillin group (0·4 vs 1·0 per 1000 live births, p = 0·06). The combined mortality rates for all pathogens were not significantly different (1·1 vs 0·7 per 1000 live births, p=0·27, for the penicillin and control groups, respectively) and were nearly equivalent when the excess number of deaths associted with penicillin-resistant infections in the penicillin group during the first study year was excluded from analysis. The incidence of gonococcal ophtalmia and chlamydial conjunctivitis was unaffected by the use of intramuscular penicillin at birth.