| CTRI Number |
CTRI/2024/07/070863 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Information regarding global developmental delay in children |
|
Scientific Title of Study
|
A Cross sectional observational study on clinical and etiological profile of global developmental delay in children.
|
| 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 K Vaswani |
| Designation |
Professor |
| Affiliation |
Seth G. S. Medical College and K.E.M. Hospital |
| Address |
Department of Pediatrics, Seth G.S. Medical College and K.E.M. Hospital, Old K.E.M. Hospital Building, Ward No. 1, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
02224107647 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rajwanti K Vaswani |
| Designation |
Professor |
| Affiliation |
Seth G. S. Medical College and K.E.M. Hospital |
| Address |
Department of Pediatrics, Seth G.S. Medical College and K.E.M. Hospital, Old K.E.M. Hospital Building, Ward No. 1, Parel, Mumbai
MAHARASHTRA 400012 India |
| Phone |
02224107647 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rajwanti K Vaswani |
| Designation |
Professor |
| Affiliation |
Seth G. S. Medical College and K.E.M. Hospital |
| Address |
Department of Pediatrics, Seth G.S. Medical College and K.E.M. Hospital, Old K.E.M. Hospital Building, Ward No. 1, Parel, Mumbai
MAHARASHTRA 400012 India |
| Phone |
02224107647 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G. S. Medical college and K.E.M. Hospital Department of paediatrics, Parel Mumbai 400012 India |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pediatrics, Seth G.S. Medical College and K.E.M. Hospital, Old K.E.M. Hospital Building, Ward No. 1, Parel, Mumbai 400012 India |
| Type of Sponsor |
Other [Nil] |
|
|
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 Rajwanti K Vaswani |
Seth G.S. Medical College and K.E.M. Hospital |
Paediatric department, Parel, Mumbai 400012 Mumbai MAHARASHTRA |
02224107647
anukvaswani@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed to be GDD |
|
| ExclusionCriteria |
| Details |
1.Isolated Developmental delay i.e. Delay in only of the four domain of
development.
2. Parents not willing to participate in the study.
3. Children with history of Neuro regression.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is hoped that this study will help to-Determine the clinical profile and the etiology for the child’s global developmental delay which can help us in providing an estimation of child’s ultimate developmental potential and organise specific treatment requirements and interventions. Counsel the family regarding the diagnosis, etiology.
|
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="101" Sample Size from India="101"
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/08/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Global developmental delay is defined as developmental quotient< 70% in 2 or more domains of development fields of gross/ fine motor, cognition, social/ personal and activities of daily living [1]. This definition a applies to children below the age of < 5 years.
In India the prevalence of GDD ranges from 3-13%[2]
GDD is one of the most common reasons for referral to a paediatric neurologist, however paucity of published literature and absence of uniform guidelines increases the complexity of clinical management of the condition.
Child development and growth is a continuous process which begins from conception and continues throughout and individual’s life, delay in any of these process possess not only clinical but a social stigma upon the child and his or her family.
So as a paediatrician one should have a thorough history and complete physical/neurological examination of patients and have idea about the etiology to limit the negative outcomes of GDD.
The identification of underlying etiology in individuals with GDD is extremely important for several reasons that go way beyond immediate management. It enhances the planning of the long term goals, prognostications, monitoring, genetic counselling and prenatal diagnosis in subsequent pregnancies. The change in the etiological profile in the last five decades is a reflection of the advances in medical technology and neuroimaging, metabolic or genetic.
Evidence suggests that developmentally supportive care in neonatal intensive care unit setting could have significant effect on mental and motor development of preterm infants at 12 and 24 months of age.[3]
Also due to paucity of data regarding the etiological profile of GDD we here intend to conduct a study with the purpose of determining the clinical and etiological profile of GDD.
Information thus obtained will be used to find the most specific etiology and use preventive and curative strategies towards it.
Also most of the studies about GDD include the age group of 0-6 years, while we are incorporating age group up till 12 years.
According to study conducted in India [4] regarding the etiology of GDD, we classified the etiological categories of 52 patients into four groups prenatal, perinatal, postnatal, and unknown causes. Prenatal causes accounted for the largest proportion of cases, with genetic factors (32.7%), chromosomal abnormalities (7.7%), congenital neurological malformations (7.7%), and congenital infection (1.9%) being the subcategories. Perinatal causes were observed in a significant proportion of cases, with hypoxic-ischemic encephalopathy (HIE, 26.9%) and intracranial hemorrhage (7.7%) being the leading subcategories. Postnatal causes (3.8%) were less common and included chronic bilirubin encephalopathy and post-meningitic sequelae. In the rest of the cases, the etiology could not be identified (11.6%). So the etiological yield in our study was approximately 89.4%. It is hoped that this study will help to-Determine the clinical profile and the etiology for the child’s global developmental delay which can help us in providing an estimation of child’s ultimate developmental potential and organise specific treatment requirements and interventions. Counsel the family regarding the diagnosis, etiology, anticipated comorbidities, investigations, management of genetic disorders, care during pregnancy and postnatal care in subsequent pregnancy, preventing infections and nutritional deficiencies in children, ensuring good health, providing opportunities for early learning and focusing on child safety measures.
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