neonatal hypoxic ischemic encephalopathy
Conditions
Interventions
Experimental group:cimetidine combined with hypothermia
Control group:Normal saline combined with mild hypothermia
Sponsors
Children’s Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The HIE group includes newborns who meet the following inclusion criteria, with a gestational age of >=36 weeks and a birth weight of >=2500 g, and who also have the following conditions: 1. Evidence of fetal distress in the uterus (including at least one of the following): (1) Acute perinatal events, such as placental abruption or umbilical cord prolapse, or severe abnormal fetal heart rate variability or delayed deceleration; (2) Cord blood pH < 7.0 or BE <= -12 mmol/L; 2. Evidence of neonatal asphyxia (including any one of the following 3 items): (1) Apgar score < 5 points within 5 minutes; (2) Cord blood or arterial blood gas analysis within 1 hour after birth: pH < 7.0 or BE <= -12 mmol/L; (3) Positive pressure ventilation is required for at least 10 minutes; 3. Signs of moderate or moderate to severe encephalopathy in newborns with HIE, such as drowsiness, seizures, abnormal reflexes, or neonatal hypotonia, or evidence of abnormal brain function monitoring using aEEG.
Exclusion criteria
Exclusion criteria: Exclusion criteria (if any of the following items are met, they are excluded): 1. Plan to remove life support immediately; 2. Craniocerebral trauma or moderate to severe intracranial hemorrhage; 3. Clinically prone to spontaneous bleeding or platelet count < 50 × 10^9/L; 4. Uncontrolled hypoxia caused by persistent pulmonary hypertension. A comprehensive neurological assessment was conducted by a researcher at the time of registration. The severity of HIE is graded based on the Sarnat assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Head MRI;Head ultrasound;electroencephalogram;Bayley scales of infant development;Hearing Test;examination of visual acuity;Head circumference; | — |
Secondary
| Measure | Time frame |
|---|---|
| weight; | — |
Countries
China
Contacts
Public ContactTianming Yuan
Children’s Hospital, Zhejiang University, School of Medicine, Hangzhou, China
Outcome results
None listed