Short course versus 7-day course of intravenous antibiotics for probable neonatal septicemia: a pilot, open-label, randomized controlled trial.

OBJECTIVE

To compare a short course of antibiotics (48 to 96 hours) and a standard course of antibiotics (7 days) for probable neonatal sepsis.

DESIGN

Randomized, controlled, open-labeled trial with blocking and stratification according to birth weight.

SETTING

Tertiary care, referral, teaching hospital in Northern India.

PARTICIPANTS

Neonates >30 wks gestation and >1000 g at birth, with probable sepsis (clinical signs of sepsis, raised C reactive protein) were enrolled. Babies with major malformations, severe birth asphyxia, meningitis, bone or joint or deep-seated infection, those who were already on antibiotics, and those undergoing surgery were excluded. Neonates, who had clinically remitted on antibiotic therapy by the time a sterile blood culture report was received were randomized.

INTERVENTION

In the intervention arm, antibiotics were stopped after the 48 hour culture was reported sterile. In the control arm, antibiotics were continued to a total of 7 days.

MAIN OUTCOME MEASURE

Treatment failure defined as reappearance of signs suggestive of sepsis within 15 days of stopping antibiotics, supported by laboratory evidence and adjudicated by a blinded expert committee.

RESULTS

52 neonates were randomized to receive a short course or 7 day course (n=26 each). Baseline variables were balanced in the 2 groups. There was no significant difference in the treatment failures between the 2 groups (3 babies in the 7-day group vs none in short course group, P=0.23).

CONCLUSION

No difference in the treatment failure rates could be identified between short course and 7-day groups among neonates >30 weeks and > 1000 grams with probable sepsis.