| CTRI Number |
CTRI/2025/07/090089 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out the normal score of The Standardized Infant neurodevlopmental Assesment (SINDA) scale in Infants |
|
Scientific Title of Study
|
Establishing Normative Data for Standardized Infant neurodevlopmental Assesment (SINDA) To asses the Sensory Motor and socioemotional skills among infants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abigail Job Paradesi |
| Designation |
PG student |
| Affiliation |
Father muller college of Physiotherapy |
| Address |
Father muller college of Physiotherapy
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8754587389 |
| Fax |
|
| Email |
abidave75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anupama K |
| Designation |
Associate professor |
| Affiliation |
Father muller college of Physiotherapy |
| Address |
Father muller college of Physiotherapy
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
99013 24366 |
| Fax |
|
| Email |
anupamakarkera@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Abigail Job Paradesi |
| Designation |
PG student |
| Affiliation |
Father muller college of Physiotherapy |
| Address |
Father muller college of Physiotherapy
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8754587389 |
| Fax |
|
| Email |
abidave75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Center
Kankanaddy, Mangalore, 575002 |
|
|
Primary Sponsor
|
| Name |
Father muller institution |
| Address |
Father muller medical College and hospital Kankanaddy Mangalore 575002 |
| Type of Sponsor |
Research institution |
|
|
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 Anupama K |
Father Muller IPD OPD |
Father Muller Hospital Kankanaddy 575002
Dakshina Kannada
KARNATAKA |
99013 24366
anupamakarkera@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.50 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
Infants 6 weeks to 12 months old
Infants born at term (between 37 and 42 weeks of gestation)
Both genders
|
|
| ExclusionCriteria |
| Details |
Presence of congenital anomalies, heart diseases and orthopedic conditions,
Presence of known progressive neurological disorder (eg cerebral Palsy etc)
History of NICU stay
High risk neonates
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| sample size based on pilot study |
Calculated at baseline. only once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
06/07/2025 |
| 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
|
This is a study to establish the normative data for Standardized Infant neurodevlopmental Assesment (SINDA). This a tool used to asses neurodevlopmental delay. It has 3 components neurological scale, developmental scale and socioemotional scale. This is a very good tool as it is very feasible to use and is cost effective and doesn’t require any prior training. For SINDA to be clinically relevant norm values are necessary. Moreover early detection will lead to early intervention which will lead to better outcomes |