| CTRI Number |
CTRI/2026/02/103840 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study among different scoring systems of neonates to predict outcome in Neonatal Intensive Care Units. |
|
Scientific Title of Study
|
Comparative study among SNAPPE-II, CRIB-II and nSOFA scoring system in determining mortality and morbidity of neonates in a Neonatal care unit in Tertiary care centre. |
| 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( Prof) Om Shankar Chaurasiya |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maharani Laxmi Bai Medical College, Jhansi |
| Address |
Head of the Department Cabin, 1st Floor, Department of Paediatrics, Maharani Medical College Jhansi
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9532376316 |
| Fax |
|
| Email |
chaurasiyaom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr (Prof) Om Shankar Chaurasiya |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maharani Laxmi Bai Medical College, Jhansi |
| Address |
Head of the department Cabin, floor 1, Department of Paediatrics,
Maharani Laxmi Bai Medical College,
Jhansi
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9532376316 |
| Fax |
|
| Email |
chaurasiyaom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaykeerti Dhasmana |
| Designation |
Junior Resident |
| Affiliation |
Maharani Laxmi Bai Medical College, Jhansi |
| Address |
Room no 80, Floor 1,Department of Paediatrics
Maharani Laxmi Bai Medical College,
Jhansi
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9897476710 |
| Fax |
|
| Email |
drvijaykeertidhasmana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maharani Laxmi Bai Medical College Jhansi |
| Address |
Department of Paediatrics, Maharani Laxmi Bai Medical College, Jhansi, 284128
Uttar Pradesh,India |
| 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 Vijaykeerti Dhasmana |
Maharani Laxmi Bai Medical College,Jhansi |
Neonatal Intensive Care Unit (floor 2nd, ward-5), Department of Paediatrics.
Jhansi
UTTAR PRADESH |
9897476710
drvijaykeertidhasmana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee M L B Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P09||Abnormal findings on neonatal screening, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Neonates admitted to NICU within the first 24 hours of life.
Parents/ guardians who give informed consent. |
|
| ExclusionCriteria |
| Details |
Neonates with congenital annamolies incompatible with life.
Neonates discharged or who die within six hours of NICU admission.
Incomplete clinical or laboratory data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neonatal mortality in admitted patients |
Day 1 , day 7, day 14, day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Morbidity of sample population |
3 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2026 |
| Date of Study Completion (India) |
15/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This prospective observational study aims to assess and compare the predictive accuracy of three neonatal scoring systems—SNAPPE-II, CRIB-II, and nSOFA—in determining mortality and morbidity among neonates. The study will be conducted at the Neonatal Intensive Care Unit (NICU) of MLB Medical College, Jhansi, a tertiary care center. A total of 200 neonates admitted within the first 24 hours of life will be recruited for the study. Despite the availability of various prognostic tools, uncertainty remains regarding which score offers the best balance of efficiency and feasibility in resource-limited settings. The study tests the hypothesis that there is a significant difference in the predictive accuracy of these three systems. Clinical parameters including SNAPPE-II, CRIB-II, and nSOFA scores will be recorded upon admission and correlated with clinical outcomes to identify the most effective tool for risk stratification in this population.
|