Abstract | OBJECTIVE: 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.
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Authors | Shiv Sajan Saini, Sourabh Dutta, Pallab Ray, Anil Narang |
Journal | Indian pediatrics
(Indian Pediatr)
Vol. 48
Issue 1
Pg. 19-24
(Jan 2011)
ISSN: 0974-7559 [Electronic] India |
PMID | 20972299
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Anti-Bacterial Agents
(administration & dosage)
- Bacteremia
(drug therapy, microbiology)
- Chi-Square Distribution
- Drug Administration Schedule
- Humans
- Infant, Newborn
- Infant, Newborn, Diseases
(drug therapy, microbiology)
- Injections, Intravenous
- Pilot Projects
- Treatment Failure
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