NCT07393620 Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 30 participants in total. It began in 2026-02-10 with a primary completion date of 2027-02-10.

Brief Summary

Newborns with mild hypoxic-ischemic encephalopathy usually do not receive cooling treatment. However, some of these newborns may develop neurological problems later in life. This observational study aims to evaluate whether early brain monitoring and measurements of brain oxygen levels are associated with neurological outcomes in newborns with mild hypoxic-ischemic encephalopathy. Newborns will be monitored during the first 72 hours after birth as part of routine clinical care. Neurological assessments will be performed during early infancy and later follow-up. The findings of this study may help improve early risk assessment and support closer monitoring of newborns who may be at increased risk for unfavorable neurological outcomes.

Eligibility Criteria

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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