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Oral Glycerol in newborn brain infections

Randomized comparison of oral glycerol and standard treatment versus standard treatment alone in management of neonatal bacterial meningitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005668
Enrollment
150
Registered
2015-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Neonate admitted with evidence of bacterial meningitis

Interventions

Intervention1: oral glycerol: 1.5 ml/kg/dose every 6 hourly for 48 hours Control Intervention1: Standard Treatment Alone: Standard treatment group patient will not receive the study drug (oral glycero

Sponsors

The Director
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonate (32 cells/mm3)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Composite outcome of death, severe neurological sequelae) and hearing loss.Timepoint: Composite outcome of death, severe neurological sequelae) and hearing loss.

Secondary

MeasureTime frame
Length 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.

Countries

India

Contacts

Public ContactDr Ramesh Kumar R

JIPMER

krramesh_iway@yahoo.co.in7373739142

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026