NCT07051382

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

March 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 26, 2025

Last Update Submit

June 26, 2025

Conditions

Intracranial Abscess

Outcome Measures

Primary Outcomes (1)

  • Self Administred Questioner

    Self Administred Questioner for taking the data and values

    12 Months

Interventions

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.

Eligibility Criteria

Age1 Week - 20 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohmand medical complex hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

March 17, 2025

Primary Completion

September 1, 2025

Study Completion

February 28, 2026

Last Updated

July 4, 2025

Record last verified: 2025-06

Locations

PA(1)