NCT06145256

Brief Summary

To compare between Transcranial Ultrasound , MRI and CT in patients with Hypoxic Ischemic Encephalopathyas regards diagnostic accuracy and prognostic value .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

October 18, 2023

Last Update Submit

December 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Interventions

MRI, MSCT and transcranial Ultrasound are an important diagnostic modalities in the assessment of severity and outcome of HIE

Eligibility Criteria

Age1 Hour - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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 : 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

You may qualify if:

  • 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

You may not qualify if:

  • Those newborns with :
  • CNS infections
  • sepsis
  • respiratory distress
  • metabolic disorders
  • major congenital malformations Were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Esraa Azab Abdelatty, Master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator at Assuit University pediatric department

Study Record Dates

First Submitted

October 18, 2023

First Posted

November 24, 2023

Study Start

December 10, 2023

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

December 7, 2023

Record last verified: 2023-12