| CTRI Number |
CTRI/2024/05/068197 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Kidney size measurements in preterm babies for eastern India |
|
Scientific Title of Study
|
Ultrasonographic measurements of Renal Size in Preterm infants of less than 37 weeks gestation- an Observational cross-sectional 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 |
Medha Jain |
| Designation |
DNB student |
| Affiliation |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata |
| Address |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata
Department of paediatrics
North Twentyfour Parganas
WEST BENGAL
700156
India |
| Phone |
9686036088 |
| Fax |
|
| Email |
medhaajainn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikramjit das |
| Designation |
Consultant Neonatologist |
| Affiliation |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata |
| Address |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata
Department of Pediatrics
North Twentyfour Parganas
WEST BENGAL
700156
India |
| Phone |
9216249740 |
| Fax |
|
| Email |
bikramjit.wishes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bikramjit das |
| Designation |
Consultant Neonatologist |
| Affiliation |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata |
| Address |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata
Department of Pediatrics
North Twentyfour Parganas
WEST BENGAL
700156
India |
| Phone |
9216249740 |
| Fax |
|
| Email |
bikramjit.wishes@gmail.com |
|
|
Source of Monetary or Material Support
|
| cost of ultrasound will be borne by hospital
Bhagirathi Neotia Women and child care centre, Newtown, Kolkata-700156 |
|
|
Primary Sponsor
|
| Name |
Bhagirathi Neotia women and child care centre Newtown |
| Address |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata - 700156
Finance department
Fifth floor
5th Floor |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Bikramjit Das |
Bhagirathi Neotia women and child care centre, Newtown, Kolkata |
Department of Pediatrics
Fourth floor
North Twentyfour Parganas
WEST BENGAL |
9216249740
bikramjit.wishes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HREC-BNWCCC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preterm babies |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All preterm infants of gestational age less than 37 weeks |
|
| ExclusionCriteria |
| Details |
Antenatal hydronephrosis moderate to severe
Major Congenital Malformation incompatible for life diagnosed or suspected antenatally.
Post Natally detected
Hydronephrosis moderate to severe grade
Polycystic Kidney
Single, Duplex and Ectopic Kidney
Horse shoe shaped kidney
PUJ Obstruction
Urorectal septum malformation
Bladder Exstrophy
Single Umblical Artery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To generate nomograms for renal dimensions (Length(cm), width(cm), thickness(cm) and volume(cc)).Â
2. Average Renal size in different Gestational age and Birth Weight will be known and can be used as a reference guide further |
At end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of dimensions of kidney with other parameters like
Maternal near delivery weight (within a week prior to delivery)
Maternal near delivery BMI
Maternal Socio-Economic Status (Kuppusway scale)
Infant Birth Weight
Infant Birth Length
Infant Birth Head Circumference
Infant Birth Foot length
Infant gestation at Birth
Gender of Infant |
Single (3-8 days of life) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/06/2024 |
| 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="9"
Days="1" |
|
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
|
Intend to start recruitment after getting CTRI registration numberAlthough several studies have been conducted on kidney size in various populations and paediatric age groups, very few studies with some limitations have been performed on preterm infants, which have led to a lack of sufficient data to provide optimal nomogram standards and their relation to anthropometric indices. Also there may exist possible differences in kidney sizes from various populations due to genetic factors. To our knowledge, very few studies has been performed on premature infants about the size of kidneys in eastern India. The aim of this study is to generate normative data on the size of kidneys in premature infants by ultrasonography and introduce the kidney size as a reference guide for gestational age |