Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
About this trial
This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring hypothermia, neonate, hypoxic-ischemic encephalopathy, efficacy, safety
Eligibility Criteria
Inclusion Criteria:
- Age up to 6 hours
- Gestational age ≥ 36 weeks and birth weight ≥ 2500 g
- Apgar score ≤ 3 at 1 minute and ≤ 5 at 5 minutes, and/or cord blood gas pH < 7.0 or base deficit ≤ 16 mmol/L, and/or need for resuscitation or ventilation at 5 minutes of age
- Clinical signs of encephalopathy (seizures, coma, abnormal muscle tone and irregular breathing, etc)
Exclusion Criteria:
- Major congenital abnormalities
- Infection
- Other etiology of induced brain injury
- Severe anemia (Hb < 120 g/L)
Eligible infants assessed for the severity of HIE according to criteria of the Neonatal Association of Chinese Academy of Pediatrics 25 modified from Sarnat and Sarnat 26 in 1986
Sites / Locations
- Children's Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Normothermia
Hypothermia
Rectal temperature was maintained at 36.0-37.5 degree C.
The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C. All infants were nursed under a servo-controlled radiant warmer and the rectal temperature was maintained at 34.5 to 35 degree C. Head cooling was started within 6 hours after birth for 72 hours followed by spontaneous re-warming and the average time to reach the target temperature was 2 hours.