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A glowing clue: light sensor may spot kidney damage in newborns

NCT ID NCT07743099

Diagnosis Sponsor: Agah Bahadır Öztürk,MD Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests whether a non-invasive light-based monitor, called near-infrared spectroscopy (NIRS), can detect kidney injury early in newborns with hypoxic-ischemic encephalopathy (HIE) who are undergoing cooling therapy. The monitor measures oxygen levels in the kidneys and brain continuously for 72 hours. Researchers will compare these readings between newborns who develop acute kidney injury and those who do not, to see if NIRS can serve as an early warning sign.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Continuous cerebral and bilateral renal near-infrared spectroscopy (NIRS) monitoring
What this could lead to
If successful, this could enable earlier, non-invasive detection of kidney injury in newborns with HIE, potentially improving outcomes.
What could go wrong
This is a small observational study, so results may not be conclusive. NIRS readings can be affected by various factors, and the technique may not reliably distinguish all cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

46 people

The number who actually took part.

Started

Jan 2021

Finished

Jun 2021

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Term and late-preterm neonates of gestational age 36 weeks or more admitted to the neonatal intensive care unit of Kayseri City Hospital, Kayseri, Türkiye, with a diagnosis of hypoxic-ischemic encephalopathy and treated with whole-body therapeutic hypothermia initiated within 6 hours of birth. Participants were enrolled consecutively from eligible admissions between January and June 2021.

Ages

0 minutes to 6 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute kidney injury brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Asphyxia neonatorum Hypoxic-ischemic encephalopathy Hypoxic-ischemic encephalopathy, neonatal

Contacts and locations

Locations

  • Kayseri City Hospital

    Kayseri, Kayseri, 38090, Turkey (Türkiye)

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