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CTRI Number  CTRI/2026/03/107016 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 27/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Nested observational cohort sub-study with longitudinal follow-up 
Study Design  Other 
Public Title of Study   A study of biological markers in blood to understand metabolic health in young children born small or early in Delhi, India 
Scientific Title of Study   A multi-omics sub-study to characterize metabolic and molecular pathways in early childhood among preterm and term small for gestational age children within the SAMPOORNA Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunita Taneja 
Designation  Senior Scientist and Executive Director  
Affiliation  Society for Applied Studies 
Address  45 Kalu Sarai New Delhi

South
DELHI
110016
India 
Phone  01146043751  
Fax    
Email  sunita.taneja@sas.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Rukman Manapurath 
Designation  Scientist 
Affiliation  Society for Applied Studies 
Address  45 Kalu Sarai New Delhi

South
DELHI
110016
India 
Phone  01146043751  
Fax    
Email  rukman.manapurath@sas.org.in  
 
Details of Contact Person
Public Query
 
Name  Ranadip Chowdhury 
Designation  Senior Scientist and Deputy Director 
Affiliation  Society for Applied Studies 
Address  45 Kalu Sarai New Delhi

South
DELHI
110016
India 
Phone  01146043751  
Fax    
Email  ranadip.chowdhury@sas.org.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi-110029, India 
 
Primary Sponsor  
Name  Sunita Taneja 
Address  Society for Applied Studies 45 Kalu Sarai New Delhi 110016, India 
Type of Sponsor  Other [Self] 
 
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 
Sunita Taneja  Society for Applied Studies  680, Gali No-5, Nai Basti, Devli Village, Khanpur, New Delhi-110062
South
DELHI 
01146043751-55

sunita.taneja@sas.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Review Committee Society for Applied Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children between 2 and 5 years of age  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children enrolled in the SAMPOORNA Trial with parental consent for laboratory analyses.
Eligible children include:
Preterm children
Term small for gestational age children
Term appropriate for gestational age children included from the SBT screening database 
 
ExclusionCriteria 
Details  No additional exclusion criteria beyond those defined in the parent SAMPOORNA trial (Any chronic diagnosed condition which impairs growth, or diagnosed and documented neurodevelopmental impairment currently receiving specialized therapy)
For Term appropriate for gestational age children from the Small Babies trial - no additional exclusion criteria will be applied  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plasma-based multi-omics signatures (proteomic and metabolomic markers) comparing children receiving the integrated intervention during the next 1000 days versus those receiving routine care, assessed longitudinally  Baseline and 5 years of age 
 
Secondary Outcome  
Outcome  TimePoints 
Multi Omics profiles across different birth phenotypes (preterm, term SGA, term AGA)  Baseline & 5 years of age 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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)   01/04/2026 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This multi-omics sub-study is nested within the SAMPOORNA trial and focuses on understanding metabolic and molecular pathway in early childhood among preterm and term small for gestational age children, with term appropriate for gestational age children included as a reference group. The sub-study addresses key biological questions related to the next 1000 days period from 2 to 5 years of age, an understudied phase during which growth and metabolic trajectories begin to stabilize.

Rationale and knowledge gaps

Children born preterm or small for gestational age are at higher risk for impaired growth, developmental delays, and later metabolic disease. South Asia carries a disproportionate burden of these birth phenotypes. Although interventions during the first 2 years show short term benefits, evidence is limited on sustained impacts as children enter early childhood. There is a major knowledge gap regarding the molecular processes that shape metabolic health, inflammation, hormonal regulation, and early risk pathways between ages 2 and 5 years. Conventional anthropometric indicators have limited capacity to detect early metabolic alterations, making omics approaches essential.     

Objective

The primary objective is to compare plasma based multi-omics signatures including proteomic and metabolomic markers in children receiving the integrated intervention during the next 1000 days with those receiving routine care, assessed at 2 and 5 years of age.

A secondary objective is to compare multi-omics profiles across birth phenotypes including term SGA, term AGA, and preterm children to identify intrinsic biological differences in pathways related to inflammation, adipokines, lipid and glucose metabolism, amino acids and other metabolic networks.  

Methods and sample handling

Venous blood will be collected at 2 years and at 5 years of age. Plasma will be separated, aliquoted, and stored at minus 80 degrees Celsius at the Society for Applied Studies according to standardized procedures. Buffy coat samples will also be stored for future epigenetic analysis.

All metabolomic and proteomic analysis including targeted, untargeted, and PEA based assays will be conducted at the CSIR institute of Genomics and Integrative Biology in New Delhi under established laboratory protocols. The same children will be followed from 2 to 5 years for longitudinal analyses. Quality control, random selection procedures for untargeted subsets, and appropriate calibration and normalization steps will be applied across all laboratory platforms.  


 
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