Hypoxic-Ischemic EncephalopathyPhase 1/2NCT00817401
Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
A Phase 1/2 study testing hypothermia in people with Hypoxic-Ischemic Encephalopathy, run by Zhengzhou University at 1 site in China.
Trial summary
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths globally and survivors suffer from long term neurological disability and impairment. Read more about this study
- Who is it for?
- Ages 1 hour to 10 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- hypothermia
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2002to Jun 2008
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 10 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestation age ≥37 weeks and body weight >2500g.
- with one of the following factors:
- Apgar score<5 at 5min;
- Assisted respiration >3min due to respiratory distress;
- pH≤7.1 of cord or arterial blood within 60min after birth;
- clinical manifestation of encephalopathy during the first 10 hrs of life.
Who cannot join
- Major congenital abnormalities;
- Head trauma or skull fracture causing major intracranial hemorrhage;
- Mild HIE;
- Financial problems of the parents;
- Lack of permanent address;
- Postnatal age > 10 hrs
Trial locations and contacts
1 site in 1 country.
China1 site
NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Effect of Systemic Hypothermia on Neonatal Hypoxic-Ischemic Encephalopathy
Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths globally and survivors suffer from long term neurological disability and impairment. Although many neuroprotective strategies appeared promising in animal models, most of them were not feasible and effective in human newborns. However, hypothermia was reported not to be effective if introduced beyond and thus should be introduced within 6 hrs after birth.Applying this selection criterion naturally would deprive many patients of the opportunity of hypothermia treatment.
Read the detailed description
Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high rate of death or long-term disabilities. Historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions. Recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was not effective beyond 6 hrs after brain injury. The aim of this study was to investigate whether systemic hypothermia induced up to 10 hrs after birth would improve the neurodevelopmental outcome at 18 months in infants with moderate or severe HIE.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- hypothermia
- Keywords
- asphyxia, hypothermia, hypoxic-ischemic encephalopathy, neonates
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermiaDevice
Also called TS Med 200, Germany
For the systemic hypothermia treatment (TS Med 200, Germany), the infants were nursed under an open unit, covered only by a diaper and a thin linen, loosing heat to the environment and to a cooling mat¬tress which was perfused by circulating liquid at a variable temperature. The rectal temperature was targeted at 33.5 °C (range of 33 to 34 °C) and was meant to be achieved within 60 min. The body temperature was checked every 10 min during induction hypothermia and every hour during the remaining period of cooling. The duration of hypothermia was 72 hrs. Rewarming was started by stopping the cooling system. The infant was meant to reach a 36.5°C rectal temperature in 6 hrs after stopping cooling to prevent rebound hyperthermia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and disability rate.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJul 2002
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Investigators
- Changlian Zhu, MD, PhD, Study director, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817401
- Sponsor's protocol ID
- HN-200084001
- Status last verified
- Jan 2009
- First submitted
- 2 Jan 2009
- Last updated
- 6 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes