| CTRI Number |
CTRI/2025/03/083562 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study acute kidney injury in neonates admitted in neonatal intensive care |
|
Scientific Title of Study
|
TO STUDY ACUTE KIDNEY INJURY IN NEONATES ADMITTED IN NEONATAL INTENSIVE CARE CENTRE : A CROSS SECTIONAL 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 Divya Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital , Pilibhit bypass road , Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9045959045 |
| Fax |
|
| Email |
drdivyaalg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishan Chand Gupta |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital , Pilibhit bypass road , Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8958253869 |
| Fax |
|
| Email |
drdivyaalg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital , Pilibhit bypass road , Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9045959045 |
| Fax |
|
| Email |
drdivyaalg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Divya Agarwal |
| Address |
Rohilkhand medical college and hospital , Pilibhit bypass road , Bareilly |
| Type of Sponsor |
Private 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 Divya Agarwal |
Rohilkhand Medical College and Hospital Bareilly |
Room number 3004 , Department of Paediatrics Rohilkhand Medical College and Hospital
Bareilly
UTTAR PRADESH |
9045959045
drdivyaalg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CROSS SECTIONAL STUDY |
Kidney function test (KFT) will be done in newborn at 48 hrs of life and will be repeated after 24 hrs to see the S. Creatinine level and assess the stage of AKI .
If newborn is 2 days then kidney function test will be done at the time of admission and will be repeated after 24 hrs. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates whose parents gave consent. Neonates who are admitted in NICU |
|
| ExclusionCriteria |
| Details |
Antenatally diagnosed renal congenital anomaly and preterm neonates less than 24weeks |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To minimise the potential risk of harm to neonates and assess the immediate outcome of patients |
Day 0 , 2 and 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Classify the type of AKI (prerenal or renal or postrenal ) and to assess the immediate outcome of patients.
|
Day 0, 2 and 3 |
|
|
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)
|
10/04/2025 |
| 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 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
|
All newborns’ taking part in the study, written informed consent will be taken from their parents /guardians in a language they can understand. All newborns admitted in NICU will make up the study group .Detailed history taking , complete physical examination and investigation will be done. All cases enrolled in the study will be subjected to the following Detailed maternal history like gravida , peripartum infections, history of drug in take during pregnancy, foul smelling liquor , Detailed history taking, Detailed General and Physical examination to be done , Investigations ( Complete Blood Count, Serum Electrolytes, Kidney function test , Urine routine and microscopy , C-reactive protein , Blood culture , Fractional excretion of sodium FENa ) Therefore, Kidney function test (KFT) will be done in newborn at 48 hrs of life and will be repeated after 24 hrs to see the S. Creatinine level and assess the stage of AKI . If newborn is > 2 days then kidney function test will be done at the time of admission and will be repeated after 24 hrs. Imaging – Ultrasound of whole abdomen and Computed tomography if required. Therefore, KDIGO Classification will be used to define and stage AKI.
|