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

NCT00890409 | Completed Phase 3 Results DMC

• 1 other identifier: Engineering 211
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypoxic-Ischemic Encephalopathy

Keywords

hypothermia; neonate; hypoxic-ischemic encephalopathy; efficacy; safety

Outcome Measures

Primary Outcomes (2)

• Death

  The number of deaths by 18 months of age.

  18 months

• Severe Neurodevelopmental Disability

  Severe disability was defined as cerebral palsy (CP) or mental retardation (MR). The definition of MR was development quotient (DQ) \<70 by Gesell's Child Development Scale and CP was based on the Criteria of a level 3 to 5 by the Gross Motor Function Classification System (GMFCS).

  18 months

Secondary Outcomes (1)

• Major Adverse Events

  18 months

Study Arms (2)

Normothermia

NO INTERVENTION

Rectal temperature was maintained at 36.0-37.5 degree C.

Hypothermia

EXPERIMENTAL

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)

Interventions

Cooling cap (YJW608-04B) DEVICE

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.

Also known as: YJW608-04B

Hypothermia

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Qingdao Children's Hospital: collaborator
• Guangxi Maternity and Infant health Hospital: collaborator
• Quanzhou Children's Hospital: collaborator
• The Second Hospital of Nanjing Medical University: collaborator

Study Sites (1)

Children's Hospital, Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related 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. doi: 10.1016/S0140-6736(05)17946-X.

  PMID: 15721471 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Hypothermia

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Results Point of Contact

• Title: Prof. Xiaomei Shao
• Organization: Children's Hospital, Fudan University

zhou_wenhao@yahoo.com.cn

86-21-64931913

Study Officials

• Xiaomei Shao, M.D

  Children's Hospital, Fudan University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: April 29, 2009
• Study Start: May 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: August 1, 2005
• Last Updated: May 28, 2009
• Results First Posted: April 29, 2009

Record last verified: 2009-05

Locations

CN (1)