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A study of biological markers in blood to understand metabolic health in young children born small or early in Delhi, India

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/107016
Enrollment
800
Registered
2026-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Sunita Taneja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 longitudinallyTimepoint: Baseline and 5 years of age

Secondary

MeasureTime frame
Multi Omics profiles across different birth phenotypes (preterm, term SGA, term AGA)Timepoint: Baseline & 5 years of age

Countries

India

Contacts

Public ContactRanadip Chowdhury

Society for Applied Studies

rukman.manapurath@sas.org.in01146043751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026