Clinical Research Directory

Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy

Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth. Standard treatment with cooling therapy (therapeutic hypothermia) lowers the risk of death or disability, but many infants still suffer long-term problems. This study will test whether adding stem cell therapy after cooling can further improve outcomes. The stem cells are taken from donated human placentas (Wharton's jelly-derived mesenchymal stem cells, MSCs). The cells are prepared under strict laboratory standards and checked for safety. Infants with moderate to severe HIE who have completed cooling will be randomly assigned to receive either three intravenous infusions of MSCs or placebo within the first 10 days of life. Each infusion is given over about 30 minutes while the infant is closely monitored. Researchers will follow participants for up to 2 years. The main outcome is whether MSC treatment can reduce the combined risk of death or serious developmental delay at 1 year of age. The study will also track brain MRI findings, safety events, and developmental progress at 2 years.

Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia

This prospective, single-center observational cohort study evaluated whether continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring during therapeutic hypothermia distinguishes term neonates with hypoxic-ischemic encephalopathy (HIE) who develop acute kidney injury (AKI) from those who do not. Forty-six neonates who received whole-body therapeutic hypothermia for HIE were enrolled and monitored continuously for 72 hours. Regional oxygen saturation was recorded at three sites: the cerebral cortex and both kidneys. Acute kidney injury was classified after the monitoring period using serum creatinine-based criteria, and participants were assigned to an AKI group or a non-AKI group. The primary objective was to compare regional oxygen saturation between the two groups. Serum and urinary indices of tubular function were assessed at 24, 48, and 72 hours as secondary measures.

Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

This randomized controlled trial aims to evaluate the effect of foot reflexology on comfort levels and physiological parameters in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia. Neonates in the intervention group will receive standardized foot reflexology sessions in addition to routine care, while the control group will receive routine care alone. Comfort will be assessed using the COMFORTneo scale, and physiological parameters will be monitored throughout the intervention period.