Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy

Selective Head Cooling With Mild Systemic Hypothermia After Neonatal Hypoxic-Ischemic Encephalopathy: A Multi-Center Randomized Controlled Trial in China

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000351

Enrollment

Unknown

Registered

2009-03-17

Start date

2002-05-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Neonatal Hypoxic-Ischemic Encephalopathy

Interventions

Normothermia:Rectal temperature was maintained at 36.0-37.5 deg

Hypothermia:The group was fitted with a cooling cap around the head for 72 hours to maintain the nasopharyngeal temperature at (34±0.2) degree C. Head cooling was started within 6 hours after birth.

Eligibility

Sex/Gender

All

Age

No minimum to 6 Years

Inclusion criteria

Inclusion criteria: 1. Age within 6 hours after birth; 2. Gestational age >=36 weeks and birth weight >=2500 g; 3. 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; 4. Clinical signs of encephalopathy (seizures, coma, abnormal muscle tone and irregular breathing, etc).

Exclusion criteria

Exclusion criteria: 1. Major congenital abnormalities; 2. Infection; 3. Other etiology of induced brain injury; 4. Severe anemia (Hb <120 g/L).

Design outcomes

Primary

Measure	Time frame
Desability of development of nerve system;Mortality;	—

Secondary

Measure	Time frame
Adverse event;	—

Countries

China

Contacts

Public ContactXiaomei Shao

jinqiao1977@yahoo.com.cn+86 021 64078837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026