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Short-term and long-term effects of mild hypothermia at high altitude on neonatal hypoxic-ischemic encephalopathy: a multicenter clinical cohort trial

Short-term and long-term effects of mild hypothermia at high altitude on neonatal hypoxic-ischemic encephalopathy: a multicenter clinical cohort trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021481
Enrollment
Unknown
Registered
2019-02-23
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic Ischemic Encephalopathy

Interventions

Two groups:Mild hypothermia therapy and Clinical routine treatment versus routine treatment

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Full-term infants and birthweight (> 2500g) have the following conditions at the same time: 1. Evidence of fetal distress (at least 1 item): (1) Acute perinatal events, such as placental abruption or umbilical cord prolapse or severe abnormal variation or delayed deceleration of fetal heart rate; (2) Cord blood pH 16mmol/L; 2. Evidence of neonatal asphyxia (any of the three items): (1) 5 min Apgar score 16 mmol/L within 1 hour after birth; (3) Positive pressure ventilation is required for at least 10 minutes. 3. Evidence of abnormal brain function monitoring in neonates with HIE or aEEG: Among them, abnormal brain function of aEEG: (1) upper boundary voltage 10 uV and lower boundary voltage < 5 uV (moderate abnormality); (3) Seizure.

Exclusion criteria

Exclusion criteria: Severe congenital malformations, especially complex cyanotic congenital heart disease, complex nervous system malformations, such as trisomy 21, 13 or 18 chromosomal abnormalities; severe intracranial hemorrhage; clinical tendency to spontaneous bleeding or PLT < 50 *10*9/l; brain damage caused by other reasons.

Design outcomes

Primary

MeasureTime frame
Near-infrared spectroscopy;aEEG;MRI;

Countries

China

Contacts

Public ContactJia Li

Guangzhou Women and Children's Medical Center

jiali_beijing@126.com+86 13601375142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026