Neonatal Neurological Examination to Detect Infants at Risk

Recruiting

• Conditions: Neonatal Encephalopathy

• Registration Number: NCT05772416
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

families unwilling to sign consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico gemelli; 🇮🇹 Rome, Italy