Hypoxic Ischemic EncephalopathyNCT06145256
Radiological Evaluation of Hypoxic Ischemic Encephalopathy
An observational study of Hypoxic Ischemic Encephalopathy, run by Assiut University.
Trial summary
To compare between Transcranial Ultrasound , MRI and CT in patients with Hypoxic Ischemic Encephalopathyas regards diagnostic accuracy and prognostic value . Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy
- What is being tested?
- MRI brain, MSCT brain, Transcranial Ultrasound
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2023to 31 Mar 2025
- Phase
- Observational
- 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 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: * study population comprised of all term and preterm newborns who suffered perinatal asphyxia and all neonatal with clinical manifestations suggestive of hypoxic ischemic encephalopathy : 1. disturbed level of consciousness 2. low apgar score 3_ low pH in blood gases within the first hours of delivery 4_ neonatal seizures within first 48 h of delivery and excluded Those newborns with : <!-- --> 1. CNS infections 2. sepsis 3. respiratory distress 4. metabolic disorders 5. major congenital malformations From the study
Who may be able to join
- all term and preterm newborns who suffered perinatal asphyxia and all neonatal with clinical manifestations suggestive of hypoxic ischemic encephalopathy :
- disturbed level of consciousness
- low apgar score 3_ low pH in blood gases within the first hours of delivery 4_ neonatal seizures within first 48 h of delivery
Who cannot join
- Those newborns with :
- CNS infections
- sepsis
- respiratory distress
- metabolic disorders
- major congenital malformations Were excluded from the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radiological Evaluation of Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit Of Assuit University Children's Hospital
To compare between Transcranial Ultrasound , MRI and CT in patients with Hypoxic Ischemic Encephalopathyas regards diagnostic accuracy and prognostic value .
Read the detailed description
- Hypoxic Ischemic Encephalopathy (HIE) is an injury to the brain, occurring in the neonatal period (under 28 days old) in which there is deprivation of oxygen supply to brain. It is a common cause of neonate mortality and developmental psychomotor disorders in the pediatric population worldwide.This is one of the major causes of cerebral palsy."
- Hypoxic ischemic encephalopathy (HIE) is one of the most serious birth complications affecting full term infants. It occurs in 1.5 to 2.5 per 1000 live births in developed countries and 2.3-26.5 per 1000 live births in developing countries . The incidence of HIE has not declined even with advances in obstetric care (i.e. fetal monitoring) aimed at preventing the hypoxicischemic event; thus much of the current neonatal research about HIE focuses on minimizing the extent of subsequent brain injury.
- HIE is a disorder in which clinical manifestations indicate brain dysfunction.While the exact cause is not always identified, antecedents include cord prolapse, uterine rupture, abruptio placenta, placenta previa, maternal hypotension, breech presentation, or shoulder dystonia. The manifestations of perinatal HIE in early postnatal life include abnormal fetal heart rate tracings, poor umbilical cord gases (pH < 0.7 or base deficit ≥ 12 mmol/L),low Apgar scores, presence of meconium stained fluid,or the need for respiratory support within the first several minutes of postnatal life.
- The infant usually develops seizure within first 24 h of life. Children with periventricular leukomalacia (PVL) may develop spastic CP in the form of diplegia, quadriplegia, or hemiplegia.Involvement of subcortical white matter produces severe mental retardation and impaired vision.Basal ganglia (BG) and thalamic involvement result in extrapyramidal symptoms. Multicystic encephalopathy is associated with quadriplegia, bulbar and choreoathetoid symptoms, microcephaly and mental retardation. Abnormal electroencephalographic (EEG) findings may predict adverse clinical outcome such as long-term neurologic sequelae or impending death.
- Multiple neuroimaging techniques are available to visualize brain injury in the neonatal period. Cranial ultrasonography is a helpful noninvasive tool to detect antenatal onset of injury and abnormalities that may mimic HIE. Abnormalities related to HIE can be recognized with ultrasonography as well, but it will take 48-72 h to see these changes develop in the white matter or deep gray nuclei . Magnetic resonance imaging (MRI) which includes diffusion-weighted imaging (DWI) is the preferred imaging modality during the first week after birth to determine the extent of brain injury and predict neurodevelopmental outcome in infants with symptoms of HIE, without its prognostic utility being altered by therapeutic hypothermia .
- CT image could be used as important diagnostic indication in the assessment of HIE neonate CT could identify subarachnoid hemorrhage. It is valuable in clinical application
- Conditions
- Hypoxic Ischemic Encephalopathy
- Being tested
- MRI brain, MSCT brain, Transcranial Ultrasound
- 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.
MRI brain, MSCT brain, Transcranial UltrasoundDevice
MRI, MSCT and transcranial Ultrasound are an important diagnostic modalities in the assessment of severity and outcome of HIE
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine how many children born with clinical suspicion of HIE actually have radiological findings corresponding to the clinical picture
To determine how many children born with clinical suspicion of HIE ( low apgar score , low pH in blood gases within first hours of delivery, disturbed level of consciousness and neonatal seizures ) actually have radiological findings corresponding with the clinical picture
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start10 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
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.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Azab Abdelatty, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145256
- Sponsor's protocol ID
- Radiological Evaluation of HIE
- Status last verified
- Dec 2023
- First submitted
- 18 Oct 2023
- Last updated
- 7 Dec 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Evaluation of Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit Of Assuit University Children's Hospital
- ClinicalTrials.gov ID
- NCT06145256
- Acronym / sponsor ID
- Radiological Evaluation of HIE
- Conditions
- Hypoxic Ischemic Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 24 Nov 2023 (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.
To compare between Transcranial Ultrasound , MRI and CT in patients with Hypoxic Ischemic Encephalopathyas regards diagnostic accuracy and prognostic value .
Detailed description
- Hypoxic Ischemic Encephalopathy (HIE) is an injury to the brain, occurring in the neonatal period (under 28 days old) in which there is deprivation of oxygen supply to brain. It is a common cause of neonate mortality and developmental psychomotor disorders in the pediatric population worldwide.This is one of the major causes of cerebral palsy."
- Hypoxic ischemic encephalopathy (HIE) is one of the most serious birth complications affecting full term infants. It occurs in 1.5 to 2.5 per 1000 live births in developed countries and 2.3-26.5 per 1000 live births in developing countries . The incidence of HIE has not declined even with advances in obstetric care (i.e. fetal monitoring) aimed at preventing the hypoxicischemic event; thus much of the current neonatal research about HIE focuses on minimizing the extent of subsequent brain injury.
- HIE is a disorder in which clinical manifestations indicate brain dysfunction.While the exact cause is not always identified, antecedents include cord prolapse, uterine rupture, abruptio placenta, placenta previa, maternal hypotension, breech presentation, or shoulder dystonia. The manifestations of perinatal HIE in early postnatal life include abnormal fetal heart rate tracings, poor umbilical cord gases (pH < 0.7 or base deficit ≥ 12 mmol/L),low Apgar scores, presence of meconium stained fluid,or the need for respiratory support within the first several minutes of postnatal life.
- The infant usually develops seizure within first 24 h of life. Children with periventricular leukomalacia (PVL) may develop spastic CP in the form of diplegia, quadriplegia, or hemiplegia.Involvement of subcortical white matter produces severe mental retardation and impaired vision.Basal ganglia (BG) and thalamic involvement result in extrapyramidal symptoms. Multicystic encephalopathy is associated with quadriplegia, bulbar and choreoathetoid symptoms, microcephaly and mental retardation. Abnormal electroencephalographic (EEG) findings may predict adverse clinical outcome such as long-term neurologic sequelae or impending death.
- Multiple neuroimaging techniques are available to visualize brain injury in the neonatal period. Cranial ultrasonography is a helpful noninvasive tool to detect antenatal onset of injury and abnormalities that may mimic HIE. Abnormalities related to HIE can be recognized with ultrasonography as well, but it will take 48-72 h to see these changes develop in the white matter or deep gray nuclei . Magnetic resonance imaging (MRI) which includes diffusion-weighted imaging (DWI) is the preferred imaging modality during the first week after birth to determine the extent of brain injury and predict neurodevelopmental outcome in infants with symptoms of HIE, without its prognostic utility being altered by therapeutic hypothermia .
- CT image could be used as important diagnostic indication in the assessment of HIE neonate CT could identify subarachnoid hemorrhage. It is valuable in clinical application
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- * study population comprised of all term and preterm newborns who suffered perinatal asphyxia and all neonatal with clinical manifestations suggestive of hypoxic ischemic encephalopathy : 1. disturbed level of consciousness 2. low apgar score 3_ low pH in blood gases within the first hours of delivery 4_ neonatal seizures within first 48 h of delivery and excluded Those newborns with : <!-- --> 1. CNS infections 2. sepsis 3. respiratory distress 4. metabolic disorders 5. major congenital malformations From the study
Key inclusion criteria (3 listed)
- all term and preterm newborns who suffered perinatal asphyxia and all neonatal with clinical manifestations suggestive of hypoxic ischemic encephalopathy :
Key exclusion criteria (6 listed)
- Those newborns with :
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 |
|---|---|---|
| MRI brain, MSCT brain, Transcranial UltrasoundMRI, MSCT and transcranial Ultrasound are an important diagnostic modalities in the assessment of severity and outcome of HIE | Device | – |
Primary outcome
To determine how many children born with clinical suspicion of HIE actually have radiological findings corresponding to the clinical picture
Time frame: one year
To determine how many children born with clinical suspicion of HIE ( low apgar score , low pH in blood gases within first hours of delivery, disturbed level of consciousness and neonatal seizures ) actually have radiological findings corresponding with the clinical picture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Related InfoLink provided by the sponsor.
Related trials for Hypoxic Ischemic Encephalopathy
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
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Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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The PROTECT-HIE Pilot Trial
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Neuro-MoD: Neuroplasticity With Motor Development
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic Ischemic Encephalopathy, run by Assiut University.
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 6 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Azab Abdelatty, Master (01100328593, esraaazab700@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine how many children born with clinical suspicion of HIE actually have radiological findings corresponding to the clinical picture (time frame: one year). 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 7 Dec 2023.