Predictive Value of aEEG and Cerebral Oxygenation on Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy

NCT07393620 | Recruiting

• 1 other identifier: 2025/903/17-24
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypoxic-Ischemic Encephalopathy Mild

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Correlation Between Early aEEG Background Patterns and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy

  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

  Cerebral NIRS: within the first 72 hours of life. Neurological outcomes: at 18 and 24 months of age, birth to 24 months of age.

Eligibility Criteria

• Age: 0 Hours - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of newborns with a gestational age of ≥ 36 0/7 weeks who are diagnosed with mild hypoxic-ischemic encephalopathy within the first 6 hours after birth. Eligible participants include newborns with evidence of an acute peripartum or intrapartum asphyxial event who meet blood gas and clinical criteria for hypoxic-ischemic injury but do not fulfill criteria for moderate or severe encephalopathy or for therapeutic hypothermia at enrollment. Newborns will be prospectively followed from birth up to 24 months of age to assess both short-term and long-term neurological outcomes.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (3)

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

Related Publications (7)

• Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.

  PMID: 12563063 BACKGROUND

• Chalak L. New Horizons in Mild Hypoxic-ischemic Encephalopathy: A Standardized Algorithm to Move past Conundrum of Care. Clin Perinatol. 2022 Mar;49(1):279-294. doi: 10.1016/j.clp.2021.11.016. Epub 2022 Jan 21.

  PMID: 35210007 BACKGROUND

• Kariholu U, Montaldo P, Markati T, Lally PJ, Pryce R, Teiserskas J, Liow N, Oliveira V, Soe A, Shankaran S, Thayyil S. Therapeutic hypothermia for mild neonatal encephalopathy: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):225-228. doi: 10.1136/archdischild-2018-315711. Epub 2018 Dec 19.

  PMID: 30567775 BACKGROUND

• Chalak LF, Nguyen KA, Prempunpong C, Heyne R, Thayyil S, Shankaran S, Laptook AR, Rollins N, Pappas A, Koclas L, Shah B, Montaldo P, Techasaensiri B, Sanchez PJ, Sant'Anna G. Prospective research in infants with mild encephalopathy identified in the first six hours of life: neurodevelopmental outcomes at 18-22 months. Pediatr Res. 2018 Dec;84(6):861-868. doi: 10.1038/s41390-018-0174-x. Epub 2018 Sep 13.

  PMID: 30250303 BACKGROUND

• Prempunpong C, Chalak LF, Garfinkle J, Shah B, Kalra V, Rollins N, Boyle R, Nguyen KA, Mir I, Pappas A, Montaldo P, Thayyil S, Sanchez PJ, Shankaran S, Laptook AR, Sant'Anna G. Prospective research on infants with mild encephalopathy: the PRIME study. J Perinatol. 2018 Jan;38(1):80-85. doi: 10.1038/jp.2017.164. Epub 2017 Nov 2.

  PMID: 29095433 BACKGROUND

• Conway JM, Walsh BH, Boylan GB, Murray DM. Mild hypoxic ischaemic encephalopathy and long term neurodevelopmental outcome - A systematic review. Early Hum Dev. 2018 May;120:80-87. doi: 10.1016/j.earlhumdev.2018.02.007. Epub 2018 Feb 26.

  PMID: 29496329 BACKGROUND

• Murray DM, O'Connor CM, Ryan CA, Korotchikova I, Boylan GB. Early EEG Grade and Outcome at 5 Years After Mild Neonatal Hypoxic Ischemic Encephalopathy. Pediatrics. 2016 Oct;138(4):e20160659. doi: 10.1542/peds.2016-0659. Epub 2016 Sep 20.

  PMID: 27650049 BACKGROUND

Central Study Contacts

Salih Çağrı Çakır

CONTACT

+90 533 3453739; salihcagri@uludag.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 6, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 10, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)