FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065390 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 07/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   WHETHER IL6 LEVELS IN CSF AIDS IN DIAGNOSIS OF NEONATAL MENINGITIS 
Scientific Title of Study   A STUDY ON CEREBROSPINAL FLUID INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL MENINGITIS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NIVEDEETHA K 
Designation  1ST YEAR POST GRADUATE STUDENT PEDIATRIC MEDICINE 
Affiliation  INDIRA GANDHI INSTITUTE OF CHILD HEALTH 
Address  NICU THESIS STUDENT, 1ST FLOOR INDIRA GANDHI INSTITUTE OF CHILD HEALTH, 1ST BLOCK , SIDDAPURA, JAYANAGAR, BANGALORE

Bangalore
KARNATAKA
560029
India 
Phone  8095218921  
Fax    
Email  drnivedithak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR NIRANJAN H S 
Designation  PROFESSOR 
Affiliation  INDIRA GANDHI INSTITUTE OF CHILD HEALTH 
Address  DEPARTMENT OF NEONATOLOGY, NICU 1ST FLOOR INDIRA GANDHI INSTITUTE OF CHILD HEALTH 1ST BLOCK SIDDAPURA JAYANAGAR, BANGALORE

Bangalore
KARNATAKA
560029
India 
Phone  9448046435  
Fax    
Email  drniranjan_hs@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR NIVEDEETHA K 
Designation  1ST YEAR POST GRADUATE STUDENT 
Affiliation  INDIRA GANDHI INSTITUTE OF CHILD HEALTH 
Address  THESIS STUDENT DEPARTMENT OF NEONATOLOGY, 1ST FLOOR INDIRA GANDHI INSTITUTE OF CHILD HEALTH 1ST BLOCK SIDDAPURA JAYANAGAR BANGALORE

Bangalore
KARNATAKA
560029
India 
Phone  8095218921  
Fax    
Email  drnivedithak@gmail.com  
 
Source of Monetary or Material Support  
DR NIVEDEETHA K INDIRA GANDHI INSTITUTE OF CHILD HEALTH, BANGALORE 
 
Primary Sponsor  
Name  DR NIVEDEETHA K 
Address  PEDIATRIC MEDICINE PG STUDENT, THESIS STUDENT IN DEPARTMENT OF NEONATOLOGY, NICU 1ST FLOOR INDIRA GANDHI INSTITUTE OF CHILD HEALTH 1ST BLOCK SIDDAPURA JAYANAGAR BANGALORE  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR NIVEDEETHA K  INDIRA GANDHI INSTITUTE OF CHILD HEALTH  DEPARTMENT OF NEONATOLOGY, 1ST FLOOR INDIRAGANDHI INSTITUTE OF CHILD HEALTH 1ST BLOCK SIDDAPURA JAYANAGAR BANGALORE
Bangalore
KARNATAKA 		 8095218921

drnivedithak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee igich bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00||Bacterial meningitis, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  1. Neonates less than 28 days of age
2. Clinical suspicion of sepsis
3. Indication for lumbar puncture as per unit protocol 
 
ExclusionCriteria 
Details  1. Neonates who had received antibiotics for ≥ 3 days
2. Recent brain surgery/ventricular tap
3. Moribound condition in which life expectancy less than 24hours
4. Grossly traumatic taps
5. Major congenital malformations – meningomyelocele /vertebral anamolies.
6. Presence of deep seated focus of infection other than meningitis e.g. abscess, septic arthritis etc.
7. Hemodynamic instability, bleeding disorder and coagulopathy.
8. Presence of infection at the lumbar puncture site. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
cerebrospinal fluid analysis in neonates
TERM newborn : WBC more than 8 cells And Glucose less than 20 mg/dl OR Protein more than 120mg/dl
PRETERM: WBC more than 10 cells And Glucose less than 24mg/dl OR Protein more than 170mg/dl
With or without CSF culture positivity. 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="159"
Sample Size from India="159" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   CSF culture is considered the gold standard for diagnosing bacterial meningitis. However, CSF culture typically takes atleast two days or more to be positive. and limited positivity rate (7.6percent). It is estimated that 30 to
50percent of neonatal samples are contaminated with blood, Increasing the white blood cell count and proteins.  Interleukin 6, is transiently produced in response to infections and tissue injuries. Numerous studies have supported the role of interleukin 6 as a early biomarker of meningitis in adult and paediatric population, whereas limited number of studies noted in neonates. Thus ,this study tries to assess the role of interleukin 6 as the early biomarker in diagnosis of neonatal meningitis. 
Close