| CTRI Number |
CTRI/2024/05/066735 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
KAP Survey |
| Study Design |
Other |
|
Public Title of Study
|
Helping children thrive: Enhancing early detection of developmental delays in doctors offices. |
|
Scientific Title of Study
|
Screening for developmental delay in primary care settings: Review of current practices and recommendation for improvement. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KOLLISETTI DIVYA SREE |
| Designation |
PG Student |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Paediatric Department,
Rainbow Childrens Hospital, 22, Rd#10, Banjara Hills, Hyderabad,
Telangana-500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9652053164 |
| Fax |
|
| Email |
dr.divyasree.kollisetti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratima Giri |
| Designation |
Consultant Developmental Paediatrician |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Rainbow Childrens Hospital, 22, Rd#10, Banjara Hills, Hyderabad-500034,
Telangana-500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9154031562 |
| Fax |
|
| Email |
drpratima.g@rainbowhospitals.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratima Giri |
| Designation |
Consultant Developmental Paediatrician |
| Affiliation |
Rainbow Childrens Hospital |
| Address |
Rainbow Childrens Hospital, 22, Rd#10, Banjara Hills, Hyderabad-500034,
Telangana-500034
Hyderabad
TELANGANA
500034
India |
| Phone |
9154031562 |
| Fax |
|
| Email |
drpratima.g@rainbowhospitals.in |
|
|
Source of Monetary or Material Support
|
| Rainbow Childrens Hospital, 22, Rd#10, Banjara Hills, Hyderabad,
Telangana, India - 500034 |
|
|
Primary Sponsor
|
| Name |
Kollisetti Divya Sree |
| Address |
Paediatrics Department, Rainbow Childrens Hospital, 22, Rd#10, Banjara Hills, Hyderabad,
Telangana-500034
|
| 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 Kollisetti Divya Sree |
Rainbow Childrens Hospital |
Paediatrics Department, Rainbow Childrens Hospital, 22, Rd#10, Banjara Hills, Hyderabad,
Telangana-500034
Hyderabad
TELANGANA |
9652053164
dr.divyasree.kollisetti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow Childrens Medicare Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Doctors how are dealing with Developmental Delay Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Primary care physicians who provide care to healthy
children as well as at risk children under 0-5 years.
|
|
| ExclusionCriteria |
| Details |
Tertiary care hospitals, Neonatal facility with developmental
follow-up clinic. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i) To measure proportion of doctors using developmental
screening tools in their practice.
ii ) To measure most commonly used developmental
screening tool in their practice. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i ) To assess physician perceptive of barriers for screening
ii ) To assess physicians perceptive of recommendations for
improvement. |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
11/05/2024 |
| 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="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
|
There is evidence that “Early identification of
developmental delay and early intervention leads to
improved developmental outcome.†Studies show
significant savings from early interventions, up to $18,000
per child for decreased criminality in adulthood [15].
This survey aims to assess primary care physicians’
awareness of developmental screening tools and current
practices for screening and referrals. It can improve
awareness and encourage better practices for
developmental delay detection, patient referral, early
intervention, and follow-up for high-risk children. |