Renal and Cerebral NIRS and Early Acute Kidney Injury in Cooled Neonates With Birth Asphyxia | NCT07743099

NCT07743099

Overview

NCT ID: NCT07743099
Lead Sponsor: Agah Bahadır Öztürk,MDOTHER_GOV
Official Title: Renal Oxygen Saturation Measured by Near-Infrared Spectroscopy for the Early Recognition of Acute Kidney Injury in Asphyxiated Neonates Undergoing Therapeutic Hypothermia: A Prospective Observational Cohort Study
Brief Summary: 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.

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Gestational age 36 weeks or more.

Birth weight 2,000 g or more.

Initiation of whole-body therapeutic hypothermia within 6 hours of birth.

Diagnosis of hypoxic-ischemic encephalopathy, defined by one or more of the following: cord or first-hour arterial pH 7.0 or below, or base excess -16 mmol/L or lower; 10-minute Apgar score 5 or below, or ongoing resuscitation requirement; amplitude-integrated EEG abnormality (lower margin below 5 μV, and/or upper margin below 10 μV, and/or seizure activity); modified Sarnat and Sarnat moderate-to-severe grading, or Thompson score above 7.

Written informed consent provided by a parent or legal guardian.

Exclusion Criteria:

Gestational age below 36 weeks.

Birth weight below 2,000 g.

Age greater than 6 hours at initiation of therapeutic hypothermia.

Congenital renal anomaly.

Uncontrolled persistent pulmonary hypertension, or another life-threatening cardiovascular or respiratory condition.

Major congenital anomaly, including trisomy 13, trisomy 18, or multiple organ malformations.

Uncontrolled life-threatening hemorrhage, including intracranial hemorrhage.