| CTRI Number |
CTRI/2024/05/067255 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Formulation Of a Predictive Score to detect Neonatal Sepsis |
|
Scientific Title of Study
|
DEVELOPMENT OF A COMPREHENSIVE PERINATAL AND NEONATAL PREDICTIION MODEL FOR EARLY ONSET SEPSIS IN PRETERM NEONATES BORN LESS THAN OR EQUAL TO 34 WEEKS OF GESTATION – A PROSPECTIVE COHORT STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUSHMA NANGIA |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
Lady hardinge medical college |
| Address |
Room no-335, DEPARTMENT OF NEONATOLOGY , LADY HARDINGE MEDICAL COLLEGE , NEW DELHI - 110001
Central
DELHI
110001
India |
| Phone |
9810838181 |
| Fax |
|
| Email |
drsnangia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Nangia |
| Designation |
Director Professor |
| Affiliation |
Lady hardinge medical college |
| Address |
Head of the Department, Department of Neonatology , Lady Hardinge Medical college , New Delhi ,NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9810838181 |
| Fax |
|
| Email |
drsnangia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VEENASHREE BHAT |
| Designation |
DM RESIDENT |
| Affiliation |
Lady hardinge medical college |
| Address |
Lady Hardinge Medical College, Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI
110001
India
New Delhi
DELHI
110001
India |
| Phone |
9611866182 |
| Fax |
|
| Email |
drveenashrihs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical college , New Delhi |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College NewDelhi |
| Address |
LADY HARDINGE MEDICAL COLLEGE, SHAHEED BHAGAT SINGH ROAD , Diz Area, Connaught Place , New Delhi,110001 |
| 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 SUSHMA NANGIA |
LADY HARDINGE MEDICAL COLLEGE &KALAWATI SARAN CHILDREN HOSPITAL |
DEPARTMENT OF NEONATOLOGY , ROOM NO -335
BHAGATH SINGH MARG, NEW DELHI -110001
Central
DELHI |
9810838181
drsnangia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESARCH , LHMC , DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A418||Other specified sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
All neonates born with ≤34 weeks of gestation |
|
| ExclusionCriteria |
| Details |
Major congenital anomaly (antenatally diagnosed or visible at birth) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of a “comprehensive perinatal and neonatal prediction model“ |
Till discharge or death which ever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Performance of model for culture positive sepsis
2.Performance of model for probable sepsis
|
first 3 days |
|
|
Target Sample Size
|
Total Sample Size="1180"
Sample Size from India="1180"
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)
|
27/05/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
• Most of the currently available early onset sepsis risk calculators are based on perinatal risk factors and are derived from the data collected in developed countries, which has altogether different organism profile (gram positive>> gram negative in former), clinical course, and outcome than developing countries and risk factor based approach leads to unnecessary exposure of antibiotics during the 1st week of life among asymptomatic neonates. Hence this prospective cohort study is aimed to develop comprehensive perinatal risk factor and neonatal clinical parameter based prediction model for early onset neonatal sepsis for babies born ≤ 34 weeks of gestation in developing country like India. |