| 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
|
|
|
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
|
|
|
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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