7-DAY VERSUS 10-DAY INTRAVENOUS ANTIBIOTICSFORNEONATAL SEPSIS:A RANDOMIZED CONTROLLED TRIA
Phase 4
Completed
- Conditions
- Health Condition 1: A499- Bacterial infection, unspecifiedHealth Condition 2: null- Neonatal septicemia
- Registration Number
- CTRI/2013/01/003302
- Lead Sponsor
- niversity College of Medical Sciences and Guru Teg Bahadur Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 132
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To correlate treatment failure in both groups with: <br/ ><br>ïâ??§Positive C-reactive protein on day 7 of antibiotic therapy <br/ ><br>ïâ??§The type of pathogen isolated <br/ ><br>ïâ??§Duration of hospital stay <br/ ><br>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. <br/ ><br>Timepoint: 7 days; within 28 days of discharge