Health Condition 1: A499- Bacterial infection, unspecified Health Condition 2: null- Neonatal septicemia
Conditions
Interventions
Intervention1: Antibiotic: Duration 7 days
Intervention2: Antibiotic: For 7 days duration
dose adjusted for babys weight
Ceftriaxone: 50 mg/kg/day, once daily
Amikacin, 7.5 mg/kg/dose, twice daily
Vancomycin: 10 mg/kg/dose QID
Meropenem: 20 mg/kg/dose, twice daily
Control Intervention1: An
Dose according to babys weight
Amikacin, 7.5 mg/kg/dose, twice daily
Vancomycin: 10 mg/kg/dose QID
Meropenem: 20 mg/kg/dose, twice daily
Sponsors
University College of Medical Sciences and Guru Teg Bahadur Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Neonates delivered at �32 weeks gestation (according to modified Ballard scoring and a birth weight �1.5kg,with symptomatic culture positive sepsis.Both early and late onset neonatal sepsis will be included in the study.
Exclusion criteria
Exclusion criteria: Deep seated infections-meningitis, osteomyelitis,septic arthritis Severe birth asphyxia (1 minute Apgar score � 3) Gross congenital anomalies Symptoms persisting (non-remittance) after 5 days of antibiotic therapy Fungal sepsis Neonates residing outside 15 kms radius of GTB Hospital,Delhi. Neonates requiring central line Neonates requiring exchange transfusion Neonates on mechanical ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure: Defined by the reappearance of signs and symptoms of sepsis within 28 days of stopping antibiotics, supported by the presence of a positive blood culture growing the same organism as cultured earlier (according to the similar antibiogram as obtained previously or strain typing by pulse field gel electrophoresis where possible), OR in the absence of a positive culture, the presence of reactive CRP and as adjudicated by an expert committee.Timepoint: Within first 28 days of stopping antibiotics | — |
Secondary
| Measure | Time frame |
|---|---|
| To correlate treatment failure in both groups with: ïâ??§ Positive C-reactive protein on day 7 of antibiotic therapy ïâ??§ The type of pathogen isolated ïâ??§ Duration of hospital stay 2. To see if the pathogen implicated in relapse correlates with the pathogen isolated in the stool culture/rectal swab on the day of discharge. Timepoint: 7 days; within 28 days of discharge | — |
Countries
India
Contacts
Public ContactPooja Dewan
Outcome results
None listed