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CTRI Number  CTRI/2025/10/096233 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 18/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   A STUDY ON PREVALANCE, RISK FACTORS AND COMPLICATIONS OF NEONATES BORN SMALL FOR GESTATIONAL AGE 
Scientific Title of Study   A STUDY ON FREQUENCY, RISK FACTORS AND EARLY OUTCOMES OF NEONATES BORN SMALL FOR GESTATIONAL AGE 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Videesh Sombattina 
Designation  MBBS, Pediatric Medicine, DM ( Neonatology) 
Affiliation  Human Care Medical Charitable Trust, Manipal Hospital 
Address  Human care medical charitable trust, Room number 04, 4 th floor, Pediatric opd, Dwarka, sector 6, New delhi.

West
DELHI
110075
India 
Phone  9703733703  
Fax    
Email  videeshroy123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Videesh Sombattina 
Designation  MBBS, Pediatric Medicine, DM ( Neonatology) 
Affiliation  Human Care Medical Charitable Trust, Manipal Hospital 
Address  Human care medical charitable trust, Room number 04, 4 th floor, Pediatric opd, Dwarka, sector 6, New delhi.

West
DELHI
110075
India 
Phone  9703733703  
Fax    
Email  videeshroy123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Videesh Sombattina 
Designation  MBBS, Pediatric Medicine, DM ( Neonatology) 
Affiliation  Human Care Medical Charitable Trust, Manipal Hospital 
Address  Human care medical charitable trust, Room number 04, 4 th floor, Pediatric opd, Dwarka, sector 6 New delhi.

West
DELHI
110075
India 
Phone  9703733703  
Fax    
Email  videeshroy123@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Human Care Medical Charitable Trust Manipal hospital 
Address  Dwarka, Sector 6 West delhi 110075 
Type of Sponsor  Research institution and hospital 
 
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 Videesh sombattina  Human care medical charitable trust  Department of neonatology, Neonatal intensive care, 5 th floor, Sector 6, New delhi
West
DELHI 		 9703733703

videeshroy123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCMCT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P051||Newborn small for gestational age,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All more than or equal to 25 weeks newborns with birthweight less than 10 th centile as per fenton growth chart 
 
ExclusionCriteria 
Details  Multiple pregnancies
Major congenital anomalies
Intrauterine fetal demise or still births
Unreliable gestational estimation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Frequency of sga births
Early neonatla outcomes and complications such as hypoglycemia, hypothermia, hypocalcemia, rds, jaundice, admission and mortality
Length of hospital sta, requiring intervntions like oxygen therapy, iv fluids, antibiotics, maternal and fetal risk factors 		 At admission, at 6 hours, 12 hours, 24 hours, 48 hours abd discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Length of hospital stay, requiring interventions like oxygen therapy, iv fluids, antibiotics, maternal & fetal risk factors  At admission, at 6 hours, 12 hours, 24 hours, 48 hours abd discharge 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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)   29/10/2025 
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="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   We are coducting study on to estimate the frequency of small for gestaional age and risk factors and short term outcomes of small for gestational age

This thesis ains to determine the prevalance of SGA births, identify maternal and perinatal risk factors, and assess the early neonatal outcomes of SGA infants delivered at tertiary care hospital in India. The findings are expected to inform clinical practice, contribute to early risk identification, and support interventions aimed at improving neonatal outcomesand reducing preventable newborn deaths.

 

 

 
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