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NCT05772416 Clinical Trial

Neonatal Neurological Examination to Detect Infants at Risk

Neonatal Encephalopathy Clinical Trial

Official title:
Diagnostic Value of the Neonatal Neurological Examination to Detect Infants at Risk for Neurological Abnormalities

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05772416
Other study ID # 4313
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2025

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Eugenio Mercuri, MD
Phone +39 063015
Email eugeniomaria.mercuri@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers
Gender All
Age group 6 Hours to 1 Week
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Policlinico gemelli Rome

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hammersmith Neonatal and infant Neurological examination neurological examination witha score from 0 to 75 with 75 indicating best performance 5 years
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