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

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.