| CTRI Number |
CTRI/2024/04/065471 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
To study the value of blood culture positivity in neonatal sepsis |
|
Scientific Title of Study
|
Estimate the time to blood culture positivity in neonates with sepsis a observational study |
| 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 Murali M |
| Designation |
Post graduate student |
| Affiliation |
Indira Gandhi Institute of Child Health, Bengaluru |
| Address |
NICU, 1 st floor, Indira Gandhi Institute of Child Health, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9663501103 |
| Fax |
|
| Email |
muralimunirajulakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathik B H |
| Designation |
Associate Professor of Neonatology |
| Affiliation |
Indira Gandhi Institute of Child Health, Bengaluru |
| Address |
NICU, 1 st floor, Indira Gandhi Institute of Child Health, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9717235721 |
| Fax |
|
| Email |
prathikbh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Murali M |
| Designation |
Post graduate student |
| Affiliation |
Indira Gandhi Institute of Child Health, Bengaluru |
| Address |
NICU, 1 st floor, Indira Gandhi Institute of Child Health, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9663501103 |
| Fax |
|
| Email |
muralimunirajulakshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Child Health |
|
|
Primary Sponsor
|
| Name |
Indira gandhi institute of child health bengaluru |
| Address |
south complex dharmaram college post bengaluru 560029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Murali M |
Indira Gandhi Institute of Child Health |
NICU ,1st Floor, Indira Gandhi Institute of Child Health
Bangalore
KARNATAKA |
9663501103
muralimunirajulakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE IGICH BENGALURU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates less than 28 days.
Clinical sepsis.
Parents or guardians who has given voluntary signed written and informed consent. |
|
| ExclusionCriteria |
| Details |
Presence of central line or PICC peripherally inserted central catheter line.
Major congenital malformation.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary out come is to estimate the mean time to blood culture positivity in neonatal sepsis. |
Any time before discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Type of sepsis |
Before Discharge |
| Sepsis markers like CRP & Procalcitonin |
Before Discharge |
| Organism profile |
Before Discharge |
| Shock |
Before Discharge |
| Duration of hospital stay |
Before Discharge |
| Mortality |
Before Discharge |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/04/2024 |
| 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
|
NEONATAL SEPSIS STANDS AS A SIGNIFICANT CONTRIBUTOR TO MORTALITY AND LONG TERM COMPLICATIONS IN BOTH DEVELOPED AND DEVELOPING COUNTRIES IT RANKS THE SECOND MAJOR CAUSE OF NEONATAL MORTALITY CLAIMING OVER A MILLION LIVES ANNUALLY ,WHILE CULTURE REMAINS THE GOLD STANDARD FOR DIAGNOSIS ITS POSITIVITY RATES ARE NOTABLY LOW AND VARIABLE RANGING FROM 10 TO 15 % EARLY IDENTIFICATION OF INFECTING ORGANISM IN THE BLOOD IS CRUCIAL FOR OPTIMIZING ANTIBACTERIAL TREATMENT . TIME TO POSITIVITY PROVIDES INDIRECT INFORMATION ON THE BIOMASS REFLECTING THE BACTERAEMIA LOAD AND MICROBIAL GROWTH RATE A LOWER TIME TO POSITIVITY INDICATES A FASTER POSITVE SIGNAL SUGGEST A HIGHER INOCULUM IN THE BLOOD AND / OR A FASTER GROWTH RATE. THE AIM OF STUDY IS TO ESTIMATE THE IMPORTANCE OF TIME TO POSITIVITY AS A CRITICAL FACTOR INFLUENCING DECISION ABOUT ANTIBIOTIC TREATMENT AND ITS DURATION IN CHILDREN WITH SEPSIS |