Antibiotic combinations for infection in newborn babies
- Conditions
- Health Condition 1: null- neonates with late onset sepsis
- Registration Number
- CTRI/2013/02/003372
- Lead Sponsor
- Jawaharlal Institute of Post graduate Medical Education and Research JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
Neonates born outside JIPMER within the age group of 3 to 28 days with evidence of LOS by both clinical and lab parameters were the target group. The clinical parameters used were poor feeding, poor activity, seizures, apnoea, respiratory distress, umbilical discharge and abdominal distension while the septic screen tests included micro erythrocyte sedimentation rate (mESR), C- reactive protein (CRP), absolute neutrophil count (ANC) and band cell count. Babies with atleast one of the above clinical parameters and two positive septic screen tests were included in the study.
Babies with major congenital anomalies, extreme prematurity ( <28 weeks), very low birth weight ( <1500 grams), congenital heart disease, severe asphyxia (5 minute Apgar <5) and babies who had received antibiotics prior to admission were excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcomes were mortality prior to discharge from hospital, complications including shock, DIC, acidosis, renal failure and rehospitalisation within 2 weeks of discharge.Timepoint: within 2 weeks of discharge.
- Secondary Outcome Measures
Name Time Method treatment failure, subsequent fungal infections, duration of hospital stay, cost analysis and problems on follow up.Timepoint: 2 weeks and 1 month after discharge