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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: salihcagri@uludag.edu.tr
• Phone: +90 533 3453739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.