Neonatal Neurological Examination to Detect Infants at Risk | NCT05772416

Studies
Neonatal Neurological Examination to Detect Infants at Risk

NCT05772416

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Mar 16, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Neonatal Encephalopathy

Interventions

Not provided

Countries

Italy

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

Mar 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

Sep 1, 2021Actual

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Mar 6, 2023

First Submission Date that Met QC Criteria

Mar 6, 2023

First Posted Date

Mar 16, 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

Mar 6, 2023

Last Update Posted Date

Mar 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

Detailed Description

The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

Infants at risk of neurological abnormlaiyies, such as very pèretrm infants and infants with asphyxia or with overt neyurologocal abnormla signs suh as convilsions will be assessed with a structured neurological examination and followed over time.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hammersmith Neonatal and infant Neurological examination	neurological examination witha score from 0 to 75 with 75 indicating best performance	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions

Exclusion Criteria:

families unwilling to sign consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Hours

Maximum Age

1 Week

Standard Ages

Child

Study Population

all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eugenio Mercuri, MD	Contact	+39 063015	5340	eugeniomaria.mercuri@policlinicogemelli.it
Marika Pane, MD	Contact	063015	5340	marika.pane@policlinicogemelli.it

Overall Officials

Name	Affiliation	Role
Eugenio Mercuri	F Policlinico Gemelli IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico gemelli	Recruiting	Rome			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

only aggregate data as from consensus

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided