| CTRI Number |
CTRI/2023/06/054119 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence,Risk factors & outcomes of Acute Kidney Injury in Preterm and Term neonates |
|
Scientific Title of Study
|
Incidence,Risk factors and outcomes of Acute Kidney Injury in Preterm and Term neonates, an observational 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 B Vijay Bhaskar Reddy |
| Designation |
Junior Resident |
| Affiliation |
kasturba medical college |
| Address |
Department of pediatrics,kasturba medical college, MAHE, Manipal,576104.
Udupi
KARNATAKA
576104
India |
| Phone |
9390163514 |
| Fax |
|
| Email |
bhaskarreddy156@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leslie lewis |
| Designation |
Professor and HOD |
| Affiliation |
kasturba medical college |
| Address |
Department of pediatrics,kasturba medical college, MAHE, Manipal,576104.
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Vijay Bhaskar Reddy |
| Designation |
Junior Resident |
| Affiliation |
kasturba medical college |
| Address |
Department of pediatrics,kasturba medical college, MAHE, Manipal,576104.
KARNATAKA
576104
India |
| Phone |
9390163514 |
| Fax |
|
| Email |
bhaskarreddy156@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, PG Grant |
|
|
Primary Sponsor
|
| Name |
MAHE-PG Grant |
| Address |
Kasturba medical college, MAHE, Manipal, 576104. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| B Vijay Bhaskar Reddy |
Kasturba Hospital |
Department of pediatrics, Kasturba medical college, MAHE, Manipal.
Udupi
KARNATAKA |
9390163514
bhaskarreddy156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba Medical College and Kasturba Hospital |
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
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm and term neonates admitting to NICU |
|
| ExclusionCriteria |
| Details |
lethal chromosomal anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Etiology & Possible risk factors of AKI. |
at birth, 1 month, 2 month, 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weight, Length, Hypertension |
at Birth,1 month,2 month, 3 months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/06/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AKI is one of the most common cause of mortality and morbidity in neonates admitted to NICU. Preterm neonates have a higher risk of developing AKI due to immaturity of the kidney as Nephrogenesis is incomplete before 36 weeks of gestation. Previous studies most likely underestimated the incidence of AKI. The studies which are present now are of foreign origin. Indian studies are of low sample size and information is not adequate to analyse the risk factors and outcome studies are none. so there is a need for a study with appropriate sample size and good interpretation to find out risk factors. so that we can try to reduce the incidence and the outcome can be modified. |