Ultrasonographic Prognostic Scale of Periventricular Hemo... | NCT05918016

Studies
Ultrasonographic Prognostic Scale of Periventricular Hemorrhagic Infarction

NCT05918016

Sponsor

Manuel Sanchez Luna

Status

Unknown status

Last Update Posted

Jun 26, 2023Actual

Enrollment

360Estimated

Phase

Not provided

Conditions

Preterms
Infarction Cerebral

Interventions

Routine cranial ultrasounds

Countries

Spain

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jul 31, 2023Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Jun 7, 2023

First Submission Date that Met QC Criteria

Jun 15, 2023

First Posted Date

Jun 26, 2023Actual

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 15, 2023

Last Update Posted Date

Jun 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Manuel Sanchez Luna, Doctor, Hospital General Universitario Gregorio MarañonSponsor-Investigator

Lead Sponsor

Manuel Sanchez LunaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Observational study of preterm infant with a gestational age < 30 weeks born between 2017-2023 in Neonatal Care Unit in Gregorio Marañon Hospital (Madrid, Spain). We use a new ultrasonographic prognostic scale of periventricular hemorrhagic infarction for neurodevelopmental outcome at age 2 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Routine cranial ultrasounds	Diagnostic Test	we will use the routine cranial ultrasounds

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Periventricular Hemorrhagic Infarction	Yes or no	first month
Characteristic Sonographic		first month
Neurodevelopmental outcome at age 2 years		first month

Secondary Outcomes

Measure	Description	Time Frame
Medical records		first month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestacional Age < 30 weeks

Exclusion Criteria:

Brain malformation
Genetic syndrome
Metabolic disorders
Chromosomal abnormality
None cranial ultrasound

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Newborn with gestational age < 30 weeks

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manuel Sánchez Luna, Doctor	Contact			msluna@salud.madrid.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gregorio Marañon Hospital	Recruiting	Madrid		28007	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002544	Cerebral Infarction

Ancestor Terms

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided