Skip to main content
OpenTrials
Completed

NCT Number: NCT00890409

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoxic-Ischemic Encephalopathy Body Temperature Changes Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypothermia Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital, Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: YJW608-04B

Primary outcomes

  1. Death

    Time frame: 18 months

    The number of deaths by 18 months of age.

  2. Severe Neurodevelopmental Disability

    Time frame: 18 months

    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 outcomes

  1. Major Adverse Events

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Apr 29, 2009
Registry last updated
May 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.