Short Course Versus 7-Day Course of Intravenous Antibiotics for Probable Neonatal Septicemia: A Pilot, Open-label, Randomized Controlled Trial.
Indian Pediatr
;
2011 Jan; 48(1): 19-24
Artigo
em Inglês
| IMSEAR
| ID: sea-168740
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 outcomemeasure:
“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.
Texto completo:
DisponíveL
Índice:
IMSEAR (Sudeste Asiático)
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo prognóstico
Idioma:
Inglês
Revista:
Indian Pediatr
Ano de publicação:
2011
Tipo de documento:
Artigo
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