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.
Blood gas criteria
pH ≤ 7.00 or base deficit ≥ 16 mmol/L
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.
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.
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.
Cohort
Retrospective
Not listed
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.
Correlation Between Early aEEG Background Patterns and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
This outcome measure evaluates the correlation between: 1. Continuous amplitude-integrated electroencephalography (aEEG) monitoring will be used within the first 72 hours of life to measure the amplitude (µV) of cerebral electrical activity and to determine background patterns and sleep-wake cycling; and 2. Neurological outcomes, measured by the Bayley Scales of Infant and Toddler Development (Bayley-III) in the cognitive, motor, and language domains at 18 and 24 months of age.
Correlation Between Early Cerebral NIRS Values and Neurological Outcomes in Newborns With Mild Hypoxic-Ischemic Encephalopathy
This outcome measure evaluates the correlation between: 1. Early cerebral NIRS values within the first 72 hours of life. Cerebral oxygenation (%) values at NIRS measurements in infants, first 6 h of life, first 24 h of life, between 24-48 h, 48-72 h. 2. Neurological outcomes, measured by the Bayley Scales of Infant and Toddler Development (Bayley-III) in the cognitive, motor, and language domains at 18 and 24 months of age.
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