FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/055981 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 31/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   NEURODEVELOPMENTAL OUTCOME OF HIGH RISK NEONATES 
Scientific Title of Study   Growth and neurodevelopmental outcome of high risk babies discharged from Neonatal Intensive Care Unit in rural hospital  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Handargule Anuja Satish  
Designation  Junior resident  
Affiliation  paediatrics resident,Datta meghe institute of medical sciences 
Address  Datta Meghe Institute Of High Education and Research Department of Pediatrics

Wardha
MAHARASHTRA
442001
India 
Phone  9619113984  
Fax    
Email  anujahandargule@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR PUNAM UKE 
Designation  Associate professor 
Affiliation  associate professor,department of paediatrics,datta meghe institute of higher education and research 
Address  Datta Meghe Institute Of Higher Education and Research Department of Pediatrics

Wardha
MAHARASHTRA
442001
India 
Phone  8551839785  
Fax    
Email  drukepunam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PUNAM UKE 
Designation  Associate professor 
Affiliation  associate professor,department of paediatrics,datta meghe institute of higher education and research 
Address  Datta Meghe Institute Of High Education and Research Department of Pediatrics

Wardha
MAHARASHTRA
442001
India 
Phone  8551839785  
Fax    
Email  drukepunam@gmail.com  
 
Source of Monetary or Material Support  
jnmc,dmiher,sawangi meghe,wardha,maharashtra,india 
 
Primary Sponsor  
Name  Not applicable  
Address  Not applicable  
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 Anuja Handargule   Datta meghe institute of higher education and research   department of paediatrics,Datta meghe institute of higher education and research, wardha,maharashtra,india
Wardha
MAHARASHTRA 
9619113984

anujahandargule@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DMIHER Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  2.00 Year(s)
Gender  Both 
Details  o High risk babies discharged from Neonatal intensive care unit.
o Patients of babies giving consent for the Study. 
 
ExclusionCriteria 
Details  o Babies born with gross Congenital Malformations and syndromes
o Drop outs and failure to follow up from the study.[if followed less than three visits out of four visits]
o Parents not giving consent for the study.
o Babies with major congenital heart diseases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To study prevalence of neurodevelopmental delay of high risk babies.

2.To study neurodevelopmental outcome in relation to gestational age at birth.
 
2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
3.To study neurodevelopmental outcome in relation to birth weight.

4.To identify different etiological factors and its association with neurodevelopmental outcome in different domains.
 
1,3,6,12 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   11/08/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Every new born baby has to go through a complex process of growth and

development at various levels to ultimately emerge as a normal adult. Any

deviation in these stages of development will lead to developmental disability.

Such disability may express in various forms, which include mental retardation,

cerebral palsy, autism, attention deficit disorders, visual and hearing problems,

speech and language disorders, learning disabilities and many more. These

problems increase as birth weight decreases. Impaired neurodevelopmental

outcome is a major long-term complication of surviving premature infants,

especially extremely premature infants who are born at or below 32 weeks

gestation.1-2 Sick neonates, particularly preterm babies, very low birth weight

(VLBW) and extremely low birth weight (ELBW) babies (birth weights less

than 1500 and 1000 g respectively) with perinatalhypoxia and

hypoxic-ischaemic encephalopathy, sepsis, severe jaundice, etc. are most

vulnerable to poor neuro-developmental outcome.3These are classified as high

risk infants.

 

       Insult to the developing brain may lead to gross and fine structural

changes resulting in smaller brain size, reduced white and grey matter,

ventriculomegaly, decreased callosal projections and altered fibre tract

organization, which eventually affects neural function.4 Hence, a close

neuro-developmental follow-up of these high-risk newborns is essential for

early detection of any brain damage, to prevent or restrict a poor 

neuro-developmental outcome through early intervention.

Intrauterine and neonatal insults substantially affect the global burden of 

disease, measured in disability-adjusted life-years, because they contribute to 

both premature mortality and long-term disability.5 However, little is known 

about the severity and distribution of long-term impairments after intrauterine or 

neonatal insults. As a result, sequelae from intrauterine and neonatal insults 

have not been adequately captured in estimates of the global burden of 

disease.6,7

        In India, unfortunately, there is not enough awareness about the 

abovementioned facts and that neurodevelopment assessment has long been 

considered the domain of pediatric neurologist, and general paediatricians often 

fail to recognize the delay that had begun to set in the neonatal intensive care 

unit (NICU) graduate that had come to him for various medical problems.

Though perinatal and newborn care is improving in rural India, a section of the 

rural population is still deprived of all the available facilities, due to 

socio-economic, cultural and topographical reasons. There is very scanty data 

from this part of the globe, regarding neuro-devel-opmental outcome of high 

risk newborns and the magnitude of the problem of evolving developmental 

challenges, hence we remain oblivious of the gravity of the situation. This 

opportunity is big one to miss because, it was at this point, if early intervention 

done to modify social and psychosocial environment of the infant would have 

made a large difference to his eventual neurodevelopment outcome.​

Recognition of precipitating factors and adequate preventive measures, 

detection of early markers of developmental delay and early intervention 

measures can go a long way in preventing childhood disability.8 This calls in for 

a neuro-developmental follow-up of high risk babies by a specialized team, 

using proper scientific methodology.9

 

 

 With this background, we will venture to follow up high risk babies discharged 

from the Tertiary Newborn Care unit at wardha, a district of Maharashtra, India 

to study the prevalence of delayed development in high risk babies and identify 

their various aetiological factors and associations. Simultaneous provision of 

early intervention will also initiated as a preventive and therapeutic measure.

 

 
Close