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

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890409
• Other study ID #: Engineering 211
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2009
• Last updated: May 1, 2009
• Start date: May 2002
• Est. completion date: August 2005

Study information

• Verified date: May 2009
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).

Description:

Hypoxic-ischemic encephalopathy (HIE) remains a major cause of neonatal death and long term disabilities. Data from animal studies have shown protective effects of mild hypothermia to both the mature and immature brain. Recently research priorities have moved from bench to bedside. Several studies have shown a trend for brain protection of mild to moderate hypothermia and mild hypothermia has emerged as a promising treatment for HIE. Therefore,the investigators organized a multi-centered randomized controlled trial of selective head cooling (SHC) combined with mild systemic hypothermia in HIE newborn infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: August 2005
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypothermia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

Device:
• Cooling cap (YJW608-04B)
A semiconductor water circulation cooling device (YJW608-04B, Henyang Radio Manufactory, Hunan, China) was used to conduct head cooling. The hypothermia 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.

Locations

Country	Name	City	State
China	Children's Hospital, Fudan University	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Fudan University	Guangxi Maternity and Infant health Hospital, Qingdao Children's Hospital, Quanzhou Children's Hospital, The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		18 months	No
Primary	Severe Neurodevelopmental Disability		18 months	No
Secondary	Major Adverse Events		18 months	Yes