Actively Recruiting
Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
Led by Uludag University · Updated on 2026-05-01
30
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age of 36 0/7 weeks or more and enrollment within the first 6 hours after birth
- Umbilical cord or postnatal blood gas showing pH 7.00 or less or base deficit 16 mmol/L or more
- If pH is 7.01-7.15 or base deficit is 10-15.9 mmol/L, presence of an acute perinatal event and Apgar score 5 or less at 10 minutes or ongoing resuscitation at 10 minutes
- Clinical findings consistent with mild encephalopathy (Sarnat and Sarnat Stage 1)
- No more than two categories show moderate or severe abnormalities among level of consciousness, spontaneous activity, posture, tone, primitive reflexes, and autonomic nervous system
You will not qualify if you...
- Normal neurological examination by Sarnat and Sarnat staging
- Moderate or severe encephalopathy during the first 6 hours of life
- Clinical seizures or electrographic seizure activity on aEEG
- aEEG findings requiring therapeutic hypothermia
- Moderate or severe encephalopathy in three or more Sarnat categories
- Evaluation occurring more than 6 hours after birth
- Gestational age less than 36 weeks or birth weight less than 2000 g
- Severe or extensive intracranial hemorrhage
- Severe, life-threatening coagulopathy
- Intracerebral infarction
- Chromosomal abnormalities or major congenital anomalies involving multiple organ systems
- Lack of parental informed consent
- Cyanotic congenital heart disease
- Encephalopathy due to metabolic disorders not related to hypoxic-ischemic events
- Conditions associated with encephalopathy unrelated to acute hypoxia such as abnormal fetal growth, maternal infections, fetomaternal hemorrhage, severe neonatal sepsis, or chronic placental lesions
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Bursa City Hospital
Bursa, Turkey (Türkiye)
Actively Recruiting
2
Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
Bursa, Turkey (Türkiye)
Actively Recruiting
3
Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital
Bursa, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Salih Çağrı Çakır
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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