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CTRI Number  CTRI/2023/05/052978 [Registered on: 22/05/2023] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   PREDICTION OF ACUTE KIDNEY INJURY IN NEWBORNS 
Scientific Title of Study   VALIDATION OF THE STARZ NEONATAL ACUTE KIDNEY INJURY RISK STRATIFICATION SCORE (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  Tanvi Varshney 
Designation  Junior Resident  
Affiliation  Moti Lal Nehru Medical college, Prayagraj  
Address  Sarojini Naidu Children Hospital,Church lane,Prayagraj

Allahabad
UTTAR PRADESH
211002
India 
Phone  9568522109  
Fax    
Email  tanvi.varshney3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAnubha Shrivastava  
Designation  Professor  
Affiliation   
Address  Room no.13,Sarojini Naidu Children Hospital, Church lane,Prayagraj

Allahabad
UTTAR PRADESH
211002
India 
Phone  9236804326  
Fax    
Email  anubhashrivastava79@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tanvi Varshney 
Designation  Junior Resident  
Affiliation  Sarojini Naidu Children hospital  
Address  Sarojini Naidu Children Hospital, Church lane,Prayagraj

Allahabad
UTTAR PRADESH
211002
India 
Phone  9568522109  
Fax    
Email  tanvi.varshney3@gmail.com  
 
Source of Monetary or Material Support  
Sarojini Naidu Children Hospital, Prayagraj  
 
Primary Sponsor  
Name  None  
Address  None 
Type of Sponsor  Other [None] 
 
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 
Tanvi Varshney   Sarojini Naidu Children Hospital   Department of Paediatrics Room no 3,6
Allahabad
UTTAR PRADESH 		 9568522109

tanvi.varshney3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Moti Lal Nehru Medical college and associated Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N178||Other acute kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All Neonates (<28 days)admitted to emergency ward and NICU with established IV access to receive an IV fluid for > 48 hours to deliver nutrition and/or hydration.
 
 
ExclusionCriteria 
Details  1.The neonate died within 48 hours upon admission. 

2.The presence of any lethal chromosomal anomaly (like trisomy 13,18,anencephaly).

3.The neonate who required congenital heart surgery within the first 7 days of being delivered due to potential concurrent congenital kidney dysfunction. 

4.The neonate with previously diagnosed congenital kidney anomalies. 

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of the validity of STARZ (Sethi, Tiberwal, Agrawal, Raina, WaZir) score for the prediction of acute kidney injury in all neonates after 12 hrs of hospital admission.
 		 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
Describe the outcome of the included cohort.
Estimate the frequency and duration of usage of nephrotoxic drugs in newborns.

 		 1 year  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/05/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Early detection of AKI among neonates is important to prevent short & long term effects as well as mortality. Unfortunately no agreement has been reached on its best screening method, especially as some of the suggested markers were less accurate or impractical or not 24/7 readily unavailable in less developed centres[5].

A" Neonatal AKI Risk Prediction Scoring" was created - "STARZ" (Sethi, Tiberwal, Agrawal, Raina, Wazir) score. This scoring model is used to predict the risk of AKI in neonates any time within 7 days post admission in hospital. This score has 10 independent variables(3Continuous and, 7categorical). Some of these variables are available at the time of admission while others are reported at 12 hr post-admission. Therefore, the score can be calculated anytime post 12 hr of admission.  

For scoring each of the significant variable is assigned a score with zero indicating the reference group. The scale ranges from 0 to 100, and a cut-off score is >31.5, where a higher score is proportional to the probability of AKI occuring within 7 days.


 
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