Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild … (NCT07393620) | Clinical Trial Compass
RecruitingNot Applicable
Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
Turkey (Türkiye)30 participantsStarted 2026-02-10
Plain-language 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.
Who can participate
Age range
0 Hours – 6 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Gestational age and postnatal age:
. Blood gas criteria
. 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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurological Outcomes in Neonates with Mild Hypoxic-ischemic Encephalopathy
. 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: