Oral Glycerol in newborn brain infections
Not Applicable
Suspended
- Conditions
- Health Condition 1: null- Neonate admitted with evidence of bacterial meningitis
- Registration Number
- CTRI/2015/04/005668
- Lead Sponsor
- The Director
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Neonate (<= 28 days of age) admitted in Pediatric emergency with evidence of bacterial meningitis (Positive blood procalitonin with CSF showing >32 cells/mm3)
Exclusion Criteria
1.Neonates who received >= 2 doses of parenteral antibiotics.
2.History of birth asphyxia irrespective of hypoxic ischemic encephalopathy (HIE) stage.
3.Associated condition known to cause developmental delay like bilirubin encephalopathy, congenital malformation, syndromic neonate.
4.Known or suspected case of hearing loss.
5.Contraindication for enteral feeding like septic ileus, intestinal obstruction, necrotizing entercolitis (NEC).
6.Neonates in whom lumbar puncture is contraindicated (bleeding diathesis etc)
7.Gestation age < 37 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite outcome of death, severe neurological sequelae) and hearing loss.Timepoint: Composite outcome of death, severe neurological sequelae) and hearing loss.
- Secondary Outcome Measures
Name Time Method ength of intensive care unit stay.Timepoint: At ICU discharge.;Length of mechanical ventilation if ventilatedTimepoint: At extubation from ventilation.;Progression of systemic inflammatory response syndrome (SIRS)Timepoint: 48 hours;Length of hospital stayTimepoint: At hospital discharge.;Functional status (including hearing assessment)Timepoint: At 3 months.