Neonatal Hypoxic Ischemic EncephalopathyBBASLNCT04325230
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
A study testing Arterial Spin Labeling sequence in people with Neonatal Hypoxic Ischemic Encephalopathy, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages 1 day to 8 days
- Conditions the study is for
- Neonatal Hypoxic Ischemic Encephalopathy
- What is being tested?
- Arterial Spin Labeling sequence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2020to 12 Jan 2023
- 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 1 day to 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g.
- presenting with perinatal asphyxia defined as combination of:
- an acute perinatal event (such as placental abruption, cord prolapse, and/or severe foetal heart rate abnormalities);
- and at least one of the following criteria:
- Apgar score ≤ 5 at 10 minutes of life,
- mask ventilation or intubation at 10 minutes of life,
Show all 10Show fewer
- metabolic acidosis defined as pH < 7 or base deficit ≥ 16 mmol/L or lactates ≥ 11 mmol/L within the first 60 minutes of life on cord or other arterial venous or capillary blood sample.
- patient treated or not with therapeutic hypothermia for 72 hours.
- affiliated patient or beneficiary of a social security scheme.
- informed and signed parental consent.
Who cannot join
- perinatal arterial ischemic stroke.
- congenital neuro-metabolic disorder.
- severe malformative abnormalities.
- MRI contra-indication.
- Poor understanding of the holders of parental authority
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.
Read the detailed description
Hypoxic-ischemic encephalopathy is the result of birth asphyxia due to transitory cerebral blood flow drop during perinatal period. It is the leading cause of neonatal encephalopathy, and thus a major cause of perinatal mortality, morbidity and adverse neurodevelopmental outcome. Usual care brain MRI is critically important in the diagnosis and prognosis. Lasting about 30 to 40 minutes, MRI exam includes successive sequences providing complementary information but none relatively to brain perfusion. Perfusion MRI without contrast media injection is possible using Arterial Spin Labeling (ASL) sequence. ASL is highly suitable for neonates, noninvasiveness, and lasts only 5 minutes. However, only one study assessed ASL as a prognostic factor. The purpose of the study is therefore to perform ASL sequence within usual care brain MRI.
- Conditions
- Neonatal Hypoxic Ischemic Encephalopathy
- Being tested
- Arterial Spin Labeling sequence
- Keywords
- Hypoxic-ischemic encephalopathy, Neonate, Perfusion, MRI, Arterial Spin Labeling
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Spin Labeling sequenceDevice
ASL sequence added to the usual care brain MRI
| Study group | Role | What they receive |
|---|---|---|
| Arterial Spin Labeling sequence | Experimental | ASL sequence added to the usual care brain MRI Receives: Device: Arterial Spin Labeling sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
judged as favorable, or as adverse in case of death or cerebral palsy
Measured: 3 months of life (Month 3)
Secondary outcomes (4)
Clinical outcome
judged as favorable or as adverse
Measured: Month 6, Month 12
Prognostic performances of ASL
Prognostic performances of ASL in comparison with routinely used MRI parameters
Measured: Baseline
Quality of ASL sequences
according to visual analysis of artifacts and number of negative voxels
Measured: Baseline
Inter-observer agreement of the interpretation of the perfusion data
Intra Class correlation coefficient
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start17 May 2020
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Hypoxic Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325230
- Sponsor's protocol ID
- CHUBX 2020/01
- Other IDs
- 2020-A00299-30
- Acronym
- BBASL
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2020
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT04325230
- Acronym / sponsor ID
- BBASL / CHUBX 2020/01
- Conditions
- Neonatal Hypoxic Ischemic Encephalopathy
- Keywords
- Hypoxic-ischemic encephalopathy, Neonate, Perfusion, MRI, Arterial Spin Labeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 May 2020 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 27 Mar 2020 (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.
The main purpose of this study will be to evaluate the prognostic value at 3 months of life of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal intensive care unit.
Detailed description
Hypoxic-ischemic encephalopathy is the result of birth asphyxia due to transitory cerebral blood flow drop during perinatal period. It is the leading cause of neonatal encephalopathy, and thus a major cause of perinatal mortality, morbidity and adverse neurodevelopmental outcome. Usual care brain MRI is critically important in the diagnosis and prognosis. Lasting about 30 to 40 minutes, MRI exam includes successive sequences providing complementary information but none relatively to brain perfusion. Perfusion MRI without contrast media injection is possible using Arterial Spin Labeling (ASL) sequence. ASL is highly suitable for neonates, noninvasiveness, and lasts only 5 minutes. However, only one study assessed ASL as a prognostic factor. The purpose of the study is therefore to perform ASL sequence within usual care brain MRI.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterial Spin Labeling sequence | Experimental | Device: Arterial Spin Labeling sequenceASL sequence added to the usual care brain MRI |
Who may qualify
- Ages
- 1 day to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- neonates with a term ≥ 36 weeks of amenorrhea and birth weight ≥ 1800 g.
- presenting with perinatal asphyxia defined as combination of:
- patient treated or not with therapeutic hypothermia for 72 hours.
- affiliated patient or beneficiary of a social security scheme.
- informed and signed parental consent.
Key exclusion criteria (5 listed)
- perinatal arterial ischemic stroke.
- congenital neuro-metabolic disorder.
- severe malformative abnormalities.
- MRI contra-indication.
- Poor understanding of the holders of parental authority
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 |
|---|---|---|
| Arterial Spin Labeling sequenceASL sequence added to the usual care brain MRI | Device | Arterial Spin Labeling sequence |
Primary outcome
Clinical outcome
Time frame: 3 months of life (Month 3)
judged as favorable, or as adverse in case of death or cerebral palsy
4 secondary outcomes
Clinical outcome
Time frame: Month 6, Month 12
Prognostic performances of ASL
Time frame: Baseline
Quality of ASL sequences
Time frame: Baseline
Inter-observer agreement of the interpretation of the perfusion data
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
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Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
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 Arterial Spin Labeling sequence in people with Neonatal Hypoxic Ischemic Encephalopathy, run by University Hospital, Bordeaux at 1 site in France.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 29 May 2026. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical outcome (time frame: 3 months of life (Month 3)). 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 29 May 2026.