Hypoxic- Ischemic EncephalopathyNCT05581927
Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)
A study testing modified Whole-Body Hypothermia and standard Whole-Body Hypothermia in people with Hypoxic- Ischemic Encephalopathy and Whole-Body Hypothermia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Read more about this study
- Who is it for?
- Ages 0 to 24 hours
- Conditions the study is for
- Hypoxic- Ischemic Encephalopathy, Whole-Body Hypothermia, Brain Injury
- What is being tested?
- modified Whole-Body Hypothermia and standard Whole-Body Hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical cord blood or any blood during the first hour after birth. If, during this interval,a pH was between 7.01 and 7.15, a base deficit was between 10 and 15.9 mmol per liter. or a blood gas was not available, additional criteria were required.
- These included an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture,uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute Apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes.
- equal to or more than 36 weeks
Who cannot join
- congenital malformation
- parents' refusal
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Modified Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy
Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.
Read the detailed description
Reductions in brain temperature by 2°C to 5°C provide neuroprotection in newborn and adult animal models of brain ischemia.Brain cooling has a favorable effect on multiple pathways contributing to brain injury, including excitatory amino acids, the cerebral energy state, cerebral blood flow and metabolism, nitric oxide production, and apoptosis. Brain cooling is effective in reducing the extent of brain injury even when it is initiated up to 5.5 hours after brain ischemia in near-term sheep fetuses.But, epidemiological data showed that, in non-developed countries and areas,Whole-body hypothermia is related to the increased mortality and brain injury. The cause is unclear.
- Being tested
- modified Whole-Body Hypothermia, standard Whole-Body Hypothermia
- Medical subject headings
- Hypoxia-Ischemia, Brain, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Whole-Body HypothermiaDevice
patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure
standard Whole-Body HypothermiaDevice
patients were allocated to standard Whole-Body Hypothermia
| Study group | Role | What they receive |
|---|---|---|
| modified Whole-Body Hypothermia | Experimental | patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure. Receives: Device: modified Whole-Body Hypothermia |
| standard Whole-Body Hypothermia | Active comparator | patients were allocated to standard Whole-Body Hypothermia. Receives: Device: standard Whole-Body Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
neonates are dead during hospital
Measured: 30 days
brain injury
neonates are diagnosed with brain injury
Measured: 30 days
Secondary outcomes (6)
the incidence of suspend of Whole-Body Hypothermia
Whole-Body Hypothermia is suspended
Measured: within 3 days
the incidence of discharge according to the doctor's suggestion
neonates were discharged according to the doctor's suggestion
Measured: 2-3 weeks
the incidence of intraventricular hemorrhage
intraventricular hemorrhage was diagnosed
Measured: 2-3 week
the incidence of periventricular leukomalacia
Periventricular leukomalacia is diagnosed
Measured: within 30 days
neurodevelopmental assessment
neurodevelopment is assessed using NBNA
Measured: one month
neurodevelopmental assessment
neurodevelopment is assessed using Bayley scale
Measured: 18-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: no patients were included
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, Children's Hospital of Suzhou, Women and Children's Hospital of Guangxi, People's hospital of Guangyuan
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581927
- Sponsor's protocol ID
- Whole-Body Hypothermia
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT05581927
- Acronym / sponsor ID
- Whole-Body Hypothermia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients were included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, Children's Hospital of Suzhou, Women and Children's Hospital of Guangxi, People's hospital of Guangyuan
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.
Detailed description
Reductions in brain temperature by 2°C to 5°C provide neuroprotection in newborn and adult animal models of brain ischemia.Brain cooling has a favorable effect on multiple pathways contributing to brain injury, including excitatory amino acids, the cerebral energy state, cerebral blood flow and metabolism, nitric oxide production, and apoptosis. Brain cooling is effective in reducing the extent of brain injury even when it is initiated up to 5.5 hours after brain ischemia in near-term sheep fetuses.But, epidemiological data showed that, in non-developed countries and areas,Whole-body hypothermia is related to the increased mortality and brain injury. The cause is unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one group was allocated to standard Whole-Body Hypothermia, another group was allocated to modified Whole-Body Hypothermia
| Arm | Type | Receives |
|---|---|---|
| modified Whole-Body Hypothermia | Experimental | Device: modified Whole-Body Hypothermiapatients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure. |
| standard Whole-Body Hypothermia | Active comparator | Device: standard Whole-Body Hypothermiapatients were allocated to standard Whole-Body Hypothermia. |
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical cord blood or any blood during the first hour after birth. If, during this interval,a pH was between 7.01 and 7.15, a base deficit was between 10 and 15.9 mmol per liter. or a blood gas was not available, additional criteria were required.
- These included an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture,uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute Apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes.
- equal to or more than 36 weeks
Key exclusion criteria (2 listed)
- congenital malformation
- parents' refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Whole-Body Hypothermiapatients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure | Device | modified Whole-Body Hypothermia |
| standard Whole-Body Hypothermiapatients were allocated to standard Whole-Body Hypothermia | Device | standard Whole-Body Hypothermia |
Primary outcome
death
Time frame: 30 days
neonates are dead during hospital
brain injury
Time frame: 30 days
neonates are diagnosed with brain injury
6 secondary outcomes
the incidence of suspend of Whole-Body Hypothermia
Time frame: within 3 days
the incidence of discharge according to the doctor's suggestion
Time frame: 2-3 weeks
the incidence of intraventricular hemorrhage
Time frame: 2-3 week
the incidence of periventricular leukomalacia
Time frame: within 30 days
neurodevelopmental assessment
Time frame: one month
neurodevelopmental assessment
Time frame: 18-36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Whole-Body Hypothermia and standard Whole-Body Hypothermia in people with Hypoxic- Ischemic Encephalopathy and Whole-Body Hypothermia, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.