Trial reportEuropean journal of pediatrics2026
7-days versus 14-days antibiotic therapy in uncomplicated culture proven neonatal sepsis: a randomized control assessor-blinded trial.
Trial report in European journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The trial aimed to establish the non-inferiority of a 7-day antibiotic therapy for uncomplicated neonatal sepsis when compared to the standard 14-day therapy. This study was a parallel-group, randomized non-inferiority assessor-blinded trial conducted in a tertiary Neonatal Intensive Care Unit in Central India. Neonates weighing ≥ 1000 g with suspected sepsis were screened and those meeting criteria were enrolled. Exclusions included babies with CNS (central nervous system) infections, septic arthritis, and life-threatening congenital malformations. Participants were observed for 7 days on antibiotics and re-evaluated; those with positive blood cultures were then randomized to receive either 7 or 14 days of antibiotics. The primary outcome was the relapse of sepsis, and a sample size of 70 in each arm was calculated based on a non-inferiority margin. Follow-ups were conducted for 48 h post-antibiotic treatment and weekly for 35 days to monitor any recurrence of illness. During the study, 917 babies with suspected sepsis were admitted, of which 256 had culture-positive sepsis. After excluding those with meningitis, staphylococcus, and fungal infections, 140 babies showed improvement at day 5 and were randomized into two groups: one receiving antibiotics for 7 days and the other for 14 days, each consisting of 70 babies. Klebsiella pneumoniae was the prevalent organism. The 7-day group had a shorter hospital stay (p < 0.05) and less respiratory support (p < 0.05). Outcomes revealed a low incidence of probable relapse in both groups, with no fatalities or definitive relapses recorded.
conclusionsA 7-day antibiotic regimen for uncomplicated neonatal sepsis is not inferior to a 14-day regimen. WHAT IS KNOWN: • Unregulated use of antibiotics can lead to a myriad of problems, especially in neonates. • There is some evidence that uncomplicated neonatal sepsis can be treated with short-course antibiotics. WHAT IS NEW: • Data is lacking-especially from Central India. • This trial checks if it is possible to reduce the duration of antibiotic therapy in uncomplicated neonatal sepsis.
Indexed as
Identifiers
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Registered trials
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