Early brain monitoring and oxygen levels to predict outcomes in newborns with mild HIE

Predictive Value of Amplitude-Integrated Electroencephalography and Cerebral Tissue Oxygenation on Neurological Outcomes in Neonates With Mild Hypoxic-Ischemic Encephalopathy

This project will try to see if early aEEG monitoring and measurements of cerebral oxygen levels can predict later neurological outcomes in newborns with mild hypoxic‑ischemic encephalopathy.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 0 Hours to 6 Hours
• Sex: All
• Sponsor: Uludag University (Academic / other)
• Locations: 3 sites (Bursa and 2 other locations)
• Trial ID: NCT07393620 on ClinicalTrials.gov

What this trial studies

This is an observational study of term and near‑term newborns with mild hypoxic‑ischemic encephalopathy who are enrolled within the first 6 hours after birth. Infants will undergo routine clinical monitoring with amplitude‑integrated EEG (aEEG) and near‑infrared spectroscopy (NIRS) cerebral oxygenation measurements during the first 72 hours of life. Neurological examinations and developmental follow‑up will be performed in early infancy and at later visits to record outcomes. The study aims to link early physiologic monitoring patterns with subsequent neurodevelopment to improve early risk stratification.

Who should consider this trial

Good fit: Term or near‑term newborns (≥36 weeks) enrolled within 6 hours of birth with blood gas and clinical criteria consistent with perinatal asphyxia and classified as having mild HIE are the ideal candidates.

Not a fit: Preterm infants under 36 weeks, infants presenting after the 6‑hour window, or those with clear moderate to severe HIE (who already receive therapeutic hypothermia) are unlikely to benefit from this observational monitoring protocol.

Why it matters

Potential benefit: If successful, this approach could help identify newborns with mild HIE who are at higher risk for later neurological problems so they can get closer monitoring or earlier interventions.

How similar studies have performed: Prior work in moderate and severe HIE has shown that aEEG and NIRS patterns can correlate with outcomes and provide promising signals, but evidence specifically guiding management of mild HIE remains limited.

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.

Where this trial is running

Bursa and 2 other locations

• Bursa City Hospital — Bursa, Turkey (Türkiye) (Recruiting)
• Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine — Bursa, Turkey (Türkiye) (Recruiting)
• Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital — Bursa, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Salih Çağrı Çakır

Conditions Hypoxic-Ischemic Encephalopathy Mild; Mild Hypoxic Ischemic Encephalopathy; Amplitude-integrated electroencephalography; Cerebral oxygenation; Near infrared spectroscopy; Neonates; aEEG; NIRS