CompletedNot Applicable

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

Turkey (Türkiye)46 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range

0 Minutes – 6 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study has already been completed, has the data been published yet, and could you share what was found about using kidney oxygen monitoring with NIRS to detect early acute kidney injury in newborns with birth asphyxia?
2This trial focused on measuring kidney oxygen levels during cooling therapy for HIE — does that kind of monitoring change how doctors manage AKI in cooled newborns, or is it still considered experimental in routine care?
3Given that this was an observational study measuring oxygen saturation rather than testing a new treatment, what does it tell us about prognosis or next steps for a baby who develops AKI alongside HIE?
4Since this research was done in newborns receiving therapeutic hypothermia, how does the combination of cooling treatment and kidney injury affect decisions about medications, fluids, or other interventions our care team would use?
5Are there follow-up studies or current protocols at this hospital that use NIRS-based kidney monitoring as a result of research like this, and would our baby have access to that kind of surveillance?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Renal Regional Oxygen Saturation Measured by Near-Infrared Spectroscopy

Timeframe: Continuously throughout the 72-hour therapeutic hypothermia period, summarized as 6-hour mean values and as daily mean values for Days 1, 2, and 3.

Trial details

NCT IDNCT07743099

SponsorAgah Bahadır Öztürk,MD

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Hypoxic-Ischemic Encephalopathy trials