Short Course Versus 7-Day Course of Intravenous Antibiotics for Probable Neonatal Septicemia: A Pilot, Open-label, Randomized Controlled Trial.
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Date
2011-01
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Abstract
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.
Description
Keywords
Antibiotics, Neonatal sepsis, Duration, Short course, Treatment failure
Citation
Saini Shiv Sajan, Dutta Sourabh, Ray Pallab, Narang Anil. Short Course Versus 7-Day Course of Intravenous Antibiotics for Probable Neonatal Septicemia: A Pilot, Open-label, Randomized Controlled Trial. Indian Pediatrics. 2011 Jan; 48(1): 19-24.