New study watches newborn brains to spot hidden risks
NCT ID NCT07393620
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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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
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0 to 6 hours
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Bursa City Hospital
RECRUITINGBursa, Turkey (Türkiye)
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Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
RECRUITINGBursa, Turkey (Türkiye)
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Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital
RECRUITINGBursa, Turkey (Türkiye)