- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06145256
Radiological Evaluation of Hypoxic Ischemic Encephalopathy
December 6, 2023 updated by: Esraa Azab Abdelatty, Assiut University
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 .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esraa Azab Abdelatty, Master
- Phone Number: 01100328593
- Email: esraaazab700@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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 :
- 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 and excluded Those newborns with :
- CNS infections
- sepsis
- respiratory distress
- metabolic disorders
- major congenital malformations From the study
Description
Inclusion Criteria:
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
Exclusion Criteria:
Those newborns with :
- CNS infections
- sepsis
- respiratory distress
- metabolic disorders
- major congenital malformations Were excluded from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 10, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
March 31, 2025
Study Registration Dates
First Submitted
October 18, 2023
First Submitted That Met QC Criteria
November 21, 2023
First Posted (Actual)
November 24, 2023
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Radiological Evaluation of HIE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoxic Ischemic Encephalopathy
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Johns Hopkins UniversityUniversity of MarylandCompletedEncephalopathy, Hypoxic-IschemicUnited States
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Sajjad RahmanUnknownSevere Hypoxic Ischemic Encephalopathy | Moderate Hypoxic Ischemic EncephalopathyTurkey, Egypt, Malaysia, Qatar, Saudi Arabia, United Arab Emirates
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NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHypoxia, Brain | Hypoxia-Ischemia, Brain | Hypoxic-Ischemic Encephalopathy | Infant, Newborn | Ischemic-Hypoxic Encephalopathy | Encephalopathy, Hypoxic-IschemicUnited States
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Fondazione Policlinico Universitario Agostino Gemelli...RecruitingEncephalopathy, Hypoxic IschemicItaly
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Cliniques universitaires Saint-Luc- Université...Active, not recruitingEncephalopathy, Hypoxic-IschemicBelgium
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University Hospital, GrenobleUnknownIschemic-Hypoxic EncephalopathyFrance
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NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsTerminatedHypoxia, Brain | Hypoxia-Ischemia, Brain | Hypoxic-Ischemic Encephalopathy | Infant, Newborn | Ischemic-Hypoxic Encephalopathy | Encephalopathy, Hypoxic-IschemicUnited States
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Navy General Hospital, BeijingDaping Hospital and the Research Institute of Surgery of the Third Military... and other collaboratorsUnknownHypoxic-Ischemic EncephalopathyChina
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Istanbul Training and Research HospitalCompletedHypoxic-Ischemic EncephalopathyTurkey
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University of FloridaAmerican Heart AssociationCompleted
Clinical Trials on MRI brain, MSCT brain, Transcranial Ultrasound
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University of LeicesterNihon KohdenRecruitingStroke | Traumatic Brain Injury | Acquired Brain InjuryUnited Kingdom
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University of MinnesotaRecruitingCranial NeurosurgeryUnited States
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University of NottinghamUnknownReversible Cerebral Vasoconstriction SyndromeUnited Kingdom
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Hospital General Universitario Gregorio MarañonCompletedMyocardial Infarction | Heart Diseases | Stroke | Thrombosis | Acute DiseaseSpain
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University of FloridaNational Institute of Neurological Disorders and Stroke (NINDS); Arizona State...CompletedDepression | Stroke | Epilepsy | Schizophrenia | Parkinson Disease | Alzheimer's Disease | AutismUnited States
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Sheba Medical CenterUnknown
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Turku University HospitalNot yet recruiting
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Turku University HospitalNot yet recruitingNeonatal Stroke | Neonatal Hypoxic Ischemic Encephalopathy | Neonatal Encephalopathy, UnspecifiedFinland
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Medical University of GrazMedical University Innsbruck; Paracelsus Medical UniversityRecruiting