Prospective Cohort Study of Exosomal microRNAs as Biomarkers for Diagnosis and Therapeutic Efficacy Evaluation of Metabolic Bone Diseases in Premature Infants

What this Trial Is About

Metabolic bone disease of prematurity (MBDP) affects preterm infants due to low levels of calcium, phosphorus, and protein in their bones or metabolism problems, impacting their quality of life. The disease starts subtly and is hard to diagnose early because current methods detect it only after significant bone loss. Researchers are studying plasma exosomal microRNAs as new molecular markers that may help detect MBDP earlier and assess treatment effects to improve outcomes for very low birth weight preterm infants. This observational study includes groups based on gestational age: less than 32 weeks, 32 to 36 weeks plus 6 days, and term infants between 37 and 41 weeks plus 6 days as controls. Researchers will analyze plasma exosomal microRNAs using digital PCR to verify their specificity and sensitivity as biomarkers before and after treatment. The study aims to compare these markers and evaluate their ability to indicate treatment effectiveness. Participants will be preterm and term infants with corrected gestational age under 44 weeks. Researchers will collect plasma samples for exosome analysis at 6 months of age. The study involves monitoring clinical data and bone-related microRNA changes over time to assess diagnosis and therapeutic response. The study plans to include infants from birth up to 72 hours old and follows them through early infancy to better understand MBDP and improve diagnostic methods.

Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity