Oral versus Injectable Antibiotics in Asymptomatic Neonates Born to Mothers with Risk Factors for Sepsis: A Pilot Randomized Controlled Trial

Objective To compare oral co-amoxiclav with injectable ampicillin and amikacin for the management of asymptomatic neonates born to mothers with risk factors for infection. Methods This open label, randomized controlled trial was conducted in a tertiary care teaching hospital on neonates of gestational age >= 34 wk with maternal risk factors for infection, who were asymptomatic at birth and accepting breastfeeds. Newborns were randomized to receive either oral co-amoxiclav or injectable ampicillin and amikacin within 1-3 h after birth. Primary outcome variable was the development of clinical signs of sepsis with or without a positive blood culture by 72 h of life. Secondary outcome variables were development of sepsis with or without a positive blood culture by 7 d of life and adverse effects of drug therapy. Results One hundred twenty-six newborns were randomized to receive either oral co-amoxyclav (n = 63) or injectable ampicillin and amikacin (n = 63). Data were analyzed on intention to treat basis. Both groups were comparable with respect to maternal and neonatal characteristics. Incidence of clinical sepsis within three days of age was similar between the groups [2 (3.2%) vs. 1 (1.6%) in injectable and oral groups, respectively; RR (95% CI) 0.500 (0.047-5.373);p = 0.567]. No significant difference was noted for the development of sepsis by 1 wk [1 (1.6%) vs. 0 in injectable and oral groups, respectively; RR (95% CI) 0.333 (0.014-8.03100);p = 0.499]. Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups. Conclusions Oral co-amoxyclav is as effective as injectable ampicillin and amikacin for management of asymptomatic neonates born to mothers with risk factors for infection.