Viewing Study NCT06145256



Ignite Creation Date: 2024-05-06 @ 7:49 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06145256
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-12-07
First Post: 2023-10-18

Brief Title: Radiological Evaluation of Hypoxic Ischemic Encephalopathy
Sponsor: Assiut University
Organization: Assiut University

Study Overview

Official Title: Radiological Evaluation of Hypoxic Ischemic Encephalopathy in Neonatal Intensive Care Unit Of Assuit University Childrens Hospital
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 worldwideThis 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 15 to 25 per 1000 live births in developed countries and 23-265 per 1000 live births in developing countries The incidence of HIE has not declined even with advances in obstetric care ie 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 dysfunctionWhile 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 07 or base deficit 12 mmolLlow Apgar scores presence of meconium stained fluidor 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 hemiplegiaInvolvement of subcortical white matter produces severe mental retardation and impaired visionBasal 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None