Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New study watches newborn brains to spot hidden risks

NCT ID NCT07393620

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 30 newborns with mild hypoxic-ischemic encephalopathy (HIE) — a brain injury from low oxygen at birth. Researchers will monitor their brain activity and oxygen levels for the first 72 hours, then check their development at 18-24 months. The goal is to see if early brain readings can predict which babies might have learning or movement problems later, helping doctors decide who needs extra follow-up.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population consists of newborns with a gestational age of ≥ 36 0/7 weeks who are diagnosed with mild hypoxic-ischemic encephalopathy within the first 6 hours after birth. Eligible participants include newborns with evidence of an acute peripartum or intrapartum asphyxial event who meet blood gas and clinical criteria for hypoxic-ischemic injury but do not fulfill criteria for moderate or severe encephalopathy or for therapeutic hypothermia at enrollment. Newborns will be prospectively followed from birth up to 24 months of age to assess both short-term and long-term neurological outcomes.

Ages

0 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: 1. Gestational age and postnatal age: Gestational age ≥ 36 0/7 weeks and enrollment within the first 6 hours after birth. 2. Blood gas criteria Umbilical cord or postnatal (≤ 1 hour of life) blood gas showing: 1. pH ≤ 7.00 or base deficit ≥ 16 mmol/L 2. OR, if pH is 7.01-7.15 or base deficit is 10-15.9 mmol/L, the presence of both: * An acute perinatal event, and * Apgar score ≤ 5 at 10 minutes or ongoing resuscitation at 10 minutes of life, including the need for positive pressure ventilation. ( Evidence of an acute peripartum and intrapartum asphyxia event, defined by at least one of the following: Uterine rupture, placental abruption, umbilical cord prolapse, rupture, tight nuchal cord, maternal hemorrhage, trauma, or cardiopulmonary arrest, vasa previa, category III fetal heart rate tracing, including having either a sinusoidal pattern or absent baseline variability plus recurrent late decelerations, recurrent variable decelerations, or bradycardia.) 3. Clinical evidence of encephalopathy Findings consistent with Sarnat and Sarnat Stage 1 (mild) encephalopathy. Mild, moderate, or severe abnormalities may be present in at least one of the six categories (level of consciousness, spontaneous activity, posture, tone, primitive reflexes \[suck and Moro\], autonomic nervous system), provided that no more than two categories show moderate or severe findings. Exclusion Criteria: Newborns meeting any of the following criteria will be excluded from the study: 1. Normal neurological examination Newborns with a completely normal neurological examination according to Sarnat and Sarnat staging. 2. Moderate or severe encephalopathy within the first 6 hours of life 1. Clinical findings consistent with moderate or severe encephalopathy during the first 6 hours after birth. 2. Presence of clinical seizures. 3. aEEG findings consistent with moderate or severe encephalopathy requiring therapeutic hypothermia. 4. Evidence of electrographic seizure activity on aEEG monitoring. 3. Sarnat and Sarnat criteria for moderate-severe encephalopathy Findings consistent with moderate or severe encephalopathy in three or more Sarnat categories, classified as moderate or severe hypoxic-ischemic encephalopathy. 4. Contraindications to therapeutic hypothermia, including: * Evaluation occurring more than 6 hours after birth. * Gestational age \< 36 weeks or birth weight \< 2000 g. * Severe or extensive intracranial parenchymal hemorrhage. * Severe, life-threatening coagulopathy. * Intracerebral infarction. * Chromosomal abnormalities (e.g., trisomy 13 or 18) or major congenital anomalies involving multiple organ systems. 5. Lack of parental informed consent 6. Cyanotic congenital heart disease 7. Metabolic encephalopathy Encephalopathy due to metabolic disorders not related to hypoxic-ischemic events. 8. Other conditions associated with encephalopathy unrelated to acute hypoxia * Abnormal fetal growth. * Maternal infections. * Fetomaternal hemorrhage. * Severe neonatal sepsis. * Chronic placental lesions.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypoxic-ischemic encephalopathy mild are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bursa City Hospital

    RECRUITING

    Bursa, Turkey (Türkiye)

  • Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine

    RECRUITING

    Bursa, Turkey (Türkiye)

  • Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital

    RECRUITING

    Bursa, Turkey (Türkiye)