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Clinical Trial NCT07393620 for Hypoxic-Ischemic Encephalopathy Mild is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy 30 Observational
Predictive Value of Amplitude-Integrated Electroencephalography and Cerebral Tissue Oxygenation on Neurological Outcomes in Neonates With Mild Hypoxic-Ischemic Encephalopathy
- 2025/903/17-24
Amplitude-integrated electroencephalography
Cerebral oxygenation
Near infrared spectroscopy
Neonates
aEEG
NIRS
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Neurological Outcomes in Neonates with Mild Hypoxic-ischemic Encephalopathy | The primary outcome measure is the report of neurological outcome in children diagnosed with mild hypoxic-ischemic encephalopathy. Neurological outcome will be measured using the Bayley Scales of Infant and Toddler Development (Bayley-III) at 18-24 months of age; a standard score below 85 in at least one of the cognitive, motor, or language domains will be defined as a neurologic disorder. | at 18 and 24 months of age |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Correlation Between Early aEEG Background Patterns and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy | This outcome measure evaluates the correlation between:
1. Continuous amplitude-integrated electroencephalography (aEEG) monitoring will be used within the first 72 hours of life to measure the amplitude (µV) of cerebral electrical activity and to determine background patterns and sleep-wake cycling; and
2. Neurological outcomes, measured by the Bayley Scales of Infant and Toddler Development (Bayley-III) in the cognitive, motor, and language domains at 18 and 24 months of age. | aEEG: within the first 72 hours of life. Neurological outcomes: at 18 and 24 months of age, birth to 24 months of age. |
Correlation Between Early Cerebral NIRS Values and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy | This outcome measure evaluates the correlation between:
1. Early cerebral NIRS values within the first 72 hours of life. Cerebral oxygenation (%) values at NIRS measurements in infants, first 6 h of life, first 24 h of life, between 24-48 h, 48-72 h.
2. Neurological outcomes, measured by the Bayley Scales of Infant and Toddler Development (Bayley-III) in the cognitive, motor, and language domains at 18 and 24 months of age. | Cerebral NIRS: within the first 72 hours of life. Neurological outcomes: at 18 and 24 months of age, birth to 24 months of age. |
Gestational age and postnatal age:
Gestational age ≥ 36 0/7 weeks and enrollment within the first 6 hours after birth.
Blood gas criteria
Umbilical cord or postnatal (≤ 1 hour of life) blood gas showing:
pH ≤ 7.00 or base deficit ≥ 16 mmol/L
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.)
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.
Newborns meeting any of the following criteria will be excluded from the study:
Normal neurological examination Newborns with a completely normal neurological examination according to Sarnat and Sarnat staging.
Moderate or severe encephalopathy within the first 6 hours of life
- Clinical findings consistent with moderate or severe encephalopathy during the first 6 hours after birth.
- Presence of clinical seizures.
- aEEG findings consistent with moderate or severe encephalopathy requiring therapeutic hypothermia.
- Evidence of electrographic seizure activity on aEEG monitoring.
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.
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.
Lack of parental informed consent
Cyanotic congenital heart disease
Metabolic encephalopathy Encephalopathy due to metabolic disorders not related to hypoxic-ischemic events.
Other conditions associated with encephalopathy unrelated to acute hypoxia
- Abnormal fetal growth.
- Maternal infections.
- Fetomaternal hemorrhage.
- Severe neonatal sepsis.
- Chronic placental lesions.
Uludag University