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

This study has been completed.
Sponsor:
Collaborators:
Qingdao Children's Hospital
Guangxi Maternity and Infant health Hospital
Quanzhou Children's Hospital
The Second Hospital of Nanjing Medical University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00890409
First received: January 2, 2009
Last updated: May 1, 2009
Last verified: May 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Hypoxic-Ischemic Encephalopathy
 Device: Cooling cap (YJW608-04B)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selective Head Cooling With Mild Systemic Hypothermia After Neonatal Hypoxic-Ischemic Encephalopathy: A Multi-Center Randomized Controlled Trial in China

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Severe Neurodevelopmental Disability [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 256
Study Start Date: May 2002
Study Completion Date: August 2005
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Normothermia
Rectal temperature was maintained at 36.0-37.5 degree C.
Experimental: Hypothermia
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.
 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.
Other Name: YJW608-04B

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890409

Locations
China, Shanghai
Children's Hospital, Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Fudan University
Qingdao Children's Hospital
Guangxi Maternity and Infant health Hospital
Quanzhou Children's Hospital
The Second Hospital of Nanjing Medical University
Investigators
Study Chair: Xiaomei Shao, M.D Children's Hospital, Fudan University
  More Information

Publications:

Responsible Party: Xiaomei Shao, Children's Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00890409     History of Changes
Other Study ID Numbers: Engineering 211
Study First Received: January 2, 2009
Results First Received: January 2, 2009
Last Updated: May 1, 2009
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
hypothermia
neonate
hypoxic-ischemic encephalopathy
efficacy
safety

Additional relevant MeSH terms:
Brain Ischemia
Hypothermia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Hypoxia-Ischemia, Brain
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013