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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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