| CTRI Number |
CTRI/2025/05/087267 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using a Simple Tool to Find Early Developmental Delays in Children |
|
Scientific Title of Study
|
A Cross sectional Observational Stidy on Identification of Developmental delay and Deyermination of its Risk factors in Children less than 2 years at a Tertiary Care Centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajwanti Vaswani |
| Designation |
Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital Mumbai |
| Address |
Department of pediatrics seth GS medical college and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820879168 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajwanti Vaswani |
| Designation |
Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital Mumbai |
| Address |
Department of pediatrics seth GS medical college and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820879168 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajwanti Vaswani |
| Designation |
Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital Mumbai |
| Address |
Department of pediatrics seth GS medical college and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820879168 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College and KEM Hospital, Parel,Mumbai 400012, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr. Rajwanti Vaswani |
| Address |
Department of Paediatrics, Seth GS Medical College and KEM Hospital,Parel, Mumbai 400012,Maharashtra,India |
| Type of Sponsor |
Other [[self]] |
|
|
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 Geetanjali Gavade |
Seth GS Medical College and KEM Hospital |
Department of Paediatrics,Old Building Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
8605593907
geetanjalig1503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Z13.42: Encounter for screening for developmental delay |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1. All Children between 1 month to 2 years of age. |
|
| ExclusionCriteria |
| Details |
1. Children identified with developmental delay.
2. Parents of children not willing to participate in study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Identify prevalence of developmental delay in a community and to find out risk factors of developmental delay |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. Early identification and early intervention will help to improve neurodevelopmental outcome of children |
1 week after positive screening |
|
|
Target Sample Size
|
Total Sample Size="915"
Sample Size from India="915"
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)
|
02/06/2025 |
| 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="3"
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 study aims to identify developmental delays in young children using the Trivandrum Developmental Screening Chart, a simple cost-effective tool. Children under 2 years of age will be screened in clinical setting to detect any delays in milestones. Early identification through this method allows for timely intervention, improving the long-term outcomes for affected children. |