Transcranial Sonographic Evaluation of Preterm Neonates P... | NCT07051382

Studies
Transcranial Sonographic Evaluation of Preterm Neonates Presenting With Seizures and Its Association With IA

NCT07051382

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Jul 4, 2025Actual

Enrollment

122Actual

Phase

Not provided

Conditions

Intracranial Abscess

Interventions

Transcranial Sonographic Examination (Cranial Ultrasound)

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2025Actual

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Feb 28, 2026Estimated

First Submitted Date

Jun 26, 2025

First Submission Date that Met QC Criteria

Jun 26, 2025

First Posted Date

Jul 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2025

Last Update Posted Date

Jul 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to evaluate preterm neonates presenting with seizures using transcranial sonography (cranial ultrasound) to detect intracranial abnormalities.

Detailed Description

To determine the prevalence and types of intracranial abnormalities detected by transcranial sonography in preterm neonates who present with seizures, and to analyze the association between these findings and clinical outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Sonographic Examination (Cranial Ultrasound)	Diagnostic Test	No evidence of intracranial abnormalities such as intraventricular hemorrhage, germinal matrix hemorrhage, periventricular leukomalacia, hydrocephalus, or infarction. Brain structures were assessed to be age-appropriate for gestational development.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self Administred Questioner	Self Administred Questioner for taking the data and values	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both genders during neonatal period i.e. up to 28 days of postnatal life.
Seizures having any birth weight and gestational age.3.6.2

Exclusion Criteria:

Preterm with Congenital spinal anomalies causing seizures such as spina-bifida, scoliosisetc.
Extra-cranial anomalies causing seizures such as arteriovenous malformation (AVM) or metabolic diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Week

Maximum Age

20 Weeks

Standard Ages

Child

Study Population

This group consisted of preterm neonates who presented with seizures and showed abnormalities on cranial ultrasound, such as: Germinal Matrix ,Hemorrhage (GMH) Intraventricular, Periventricular Leukomalacia (PVL) , Hydrocephalus , Cerebral infarction or parenchymal lesions.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohmand medical complex hospital		Peshawar	Khyber Pakhtunkhwa		Pakistan