Neonatal Neurological Examination to Detect Infants at Risk

NCT ID: NCT05772416

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Neonatal Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Hours

Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugenio Mercuri

Role: PRINCIPAL_INVESTIGATOR

F Policlinico Gemelli IRCCS

Locations

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Policlinico gemelli

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Eugenio Mercuri, MD

Role: CONTACT

+39 063015 ext. 5340

Marika Pane, MD

Role: CONTACT

063015 ext. 5340

Facility Contacts

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Eugenio Mercuri

Role: primary

063015 ext. 5340

Other Identifiers

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4313

Identifier Type: -

Identifier Source: org_study_id

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