Clinical trial NCT00890409: Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
Official title: Selective Head Cooling With Mild Systemic Hypothermia After Neonatal Hypoxic-Ischemic Encephalopathy: A Multi-Center Randomized Controlled Trial in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoxic-Ischemic Encephalopathy
Keywords: hypothermia
neonate
hypoxic-ischemic encephalopathy
efficacy
safety
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Qingdao Children's Hospital
name: Guangxi Maternity and Infant health Hospital
name: Quanzhou Children's Hospital
name: The Second Hospital of Nanjing Medical University
First posted: 2009-04-29
Enrollment: 256
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Death
timeFrame: 18 months
measure: Severe Neurodevelopmental Disability
timeFrame: 18 months
Secondary outcomes:
measure: Major Adverse Events
timeFrame: 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital, Fudan University
name: Xiaomei Shao, M.D
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/S0140-6736(05)17946-X.