A clinical trial to compare the role of 14 days vs 21 days iv antibiotic in neonates with uncomplicated meningitis.
Phase 3
- Conditions
- Health Condition 1: G009- Bacterial meningitis, unspecified
- Registration Number
- CTRI/2023/06/053614
- Lead Sponsor
- Moti Lal Nehru Medical CollegePrayagraj
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
CSF proven Neonatal Meningitis
Exclusion Criteria
1.Presence of lethal chromosome abnormalities
2.Presence of severe congenital anomalies
3.Known immunodeficiency state
4.Symptomatic system congenital viral infection
5.Significant bleeding diathesis
6.Major intracranial bleed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the mortality or readmission of neonates with meningitis being <br/ ><br>treated with 14days vs 21 days antibiotic course in first 3 months of age. <br/ ><br>2.To look for recurrence of seizures or any complication for example ventriculitis, <br/ ><br>brain abscess, cerebral oedema, raised intracranial pressure, subdural empyema, <br/ ><br>hydrocephalus, infarct & sinus venous thrombosis post discharge from nicu.Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 1.To cut off the unnecessary hospital stay in resource <br/ ><br>limited areas due to longer course of antibiotics <br/ ><br>2.To decrease the development of antimicrobial resistance. <br/ ><br>3.To prevent unwanted changes in flora form in NICU with optimal duration of <br/ ><br>empirical antibiotic . <br/ ><br>4.To decrease complication related to increased duration of antibiotic treatment <br/ ><br>such as Necrotising enterocolitis etc. <br/ ><br>5.Head circumference monitoring <br/ ><br>6.Weight monitoring <br/ ><br>7.Developmental milestones achievement status.Timepoint: 3 months