| CTRI Number |
CTRI/2025/12/098290 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Markers of early kidney injury in Preterms born before 30 weeks. A study from eastern India |
|
Scientific Title of Study
|
Urinary NGAL vs Serum Cystatin C vs KDIGO defined AKI for early diagnosis of AKI in less than 30 week Preterms. A Prospective Cohort study from tertiary care centre in eastern India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bismita Nath |
| Designation |
DNB trainee |
| Affiliation |
Neotia Bhagirathi Woman and Child Care Centre |
| Address |
Department of Pediatrics and Neonatology, Neotia Bhagirathi Woman and Child Care Centre, Newtown ,Kolkata
Kolkata
WEST BENGAL
700068
India |
| Phone |
8420803440 |
| Fax |
|
| Email |
nathbismita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikramjit Das |
| Designation |
Consultant Neonatologist |
| Affiliation |
Neotia Bhagirathi Woman and Child Care Centre |
| Address |
Department of Pediatrics and Neonatology, Neotia Bhagirathi Woman and Child Care Centre, Newtown ,Kolkata
Kolkata
WEST BENGAL
700068
India |
| Phone |
9216249740 |
| Fax |
|
| Email |
bikramjit.wishes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikramjit Das |
| Designation |
Consultant Neonatologist |
| Affiliation |
Neotia Bhagirathi Woman and Child Care Centre |
| Address |
Department of Pediatrics and Neonatology, Neotia Bhagirathi Woman and Child Care Centre, Newtown ,Kolkata
WEST BENGAL
700068
India |
| Phone |
9216249740 |
| Fax |
|
| Email |
bikramjit.wishes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neotia Bhagirathi Woman and Child Care Centre Newtown Kolkata |
|
|
Primary Sponsor
|
| Name |
Neotia Bhagirathi Woman and Child Care Centre Newtown Kolkata |
| Address |
Neotia Bhagirathi Woman and Child Care Centre Newtown Kolkata 700068 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Neotia Bhagirathi Woman and Child Care Centre Newtown Kolkata |
Neotia Bhagirathi Woman and Child Care Centre, Newtown ,Kolkata 700068 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bikramjit Das |
Neotia Bhagirathi Woman and Child Care Centre |
Department of Pediatrics and Neonatology, Neotia Bhagirathi Woman and Child Care Centre, Newtown ,Kolkata- 700068
Kolkata
WEST BENGAL |
9216249740
bikramjit.wishes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BNWCC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N178||Other acute kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All inborn preterm infants of gestational age less than and equal to 30 completed weeks who are admitted in NICU will be included |
|
| ExclusionCriteria |
| Details |
1. Congenital renal anomalies (e.g., renal dysplasia, multicystic dysplastic kidney, hydronephrosis [UTDA2 onward and decrease AF]): either antenatally diagnosed or diagnosed on day 1 ultrasound.
2. Genetic or metabolic disorders affecting kidney function (e.g., autosomal recessive polycystic kidney disease, congenital nephrotic syndrome).
3. Neonates with major congenital anomalies (e.g., cardiac defects, gastrointestinal malformations).
4. Neonates with chromosomal abnormalities (e.g., trisomy 21, trisomy 18, Turner syndrome).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation between urinary NGAL, Serum Cystatin C and modified KDIGO defined AKI criteria
|
Till discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to AKI diagnosis using urinary NGAL and serum Cystatin C versus KDIGO criteria |
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/01/2026 |
| 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="1" |
|
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
|
Preterm babies are at high risk of acute kidney injury (AKI). Definition of AKI is not yet very clear in this group. Role early markers like NGAL and cystatin in comparison to current KDIGO criteria is not studied well. This study is amongst the very few and first to look at role of NGAL and Cystatin as early markers of acute renal injury in preterm infants and to compare them with currently use KDIGO criteria. Purpose of he trial is to see how NGAL and cystatin compares with KDIGO criteria in early detection of AKI in preterm infants born before 30 weeks of gestation. |