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

Primary Purpose

Hypoxic-Ischemic Encephalopathy

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cooling cap (YJW608-04B)
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxic-Ischemic Encephalopathy focused on measuring hypothermia, neonate, hypoxic-ischemic encephalopathy, efficacy, safety

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Normothermia

Hypothermia

Arm Description

Rectal temperature was maintained at 36.0-37.5 degree C.

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.

Outcomes

Primary Outcome Measures

Death
The number of deaths by 18 months of age.
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).

Secondary Outcome Measures

Major Adverse Events
Major adverse events were defined as severe arrhythmia (II or III degree A-V block or atrial or ventricular arrhythmia), major venous thrombosis, refractory hypotension (mean blood pressure less than 40 mmHg), moderate or severe scleredema (greater or equal to 20% body surface area), and severe bleeding.

Full Information

First Posted
January 2, 2009
Last Updated
May 1, 2009
Sponsor
Fudan University
Collaborators
Qingdao Children's Hospital, Guangxi Maternity and Infant health Hospital, Quanzhou Children's Hospital, The Second Hospital of Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00890409
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-Ischemic Encephalopathy
Keywords
hypothermia, neonate, hypoxic-ischemic encephalopathy, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normothermia
Arm Type
No Intervention
Arm Description
Rectal temperature was maintained at 36.0-37.5 degree C.
Arm Title
Hypothermia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cooling cap (YJW608-04B)
Other Intervention Name(s)
YJW608-04B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Death
Description
The number of deaths by 18 months of age.
Time Frame
18 months
Title
Severe Neurodevelopmental Disability
Description
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).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Major Adverse Events
Description
Major adverse events were defined as severe arrhythmia (II or III degree A-V block or atrial or ventricular arrhythmia), major venous thrombosis, refractory hypotension (mean blood pressure less than 40 mmHg), moderate or severe scleredema (greater or equal to 20% body surface area), and severe bleeding.
Time Frame
18 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaomei Shao, M.D
Organizational Affiliation
Children's Hospital, Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15721471
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.
Results Reference
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Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy

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