NCT05772416

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

March 6, 2023

Last Update Submit

March 6, 2023

Conditions

Neonatal Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • Hammersmith Neonatal and infant Neurological examination

    neurological examination witha score from 0 to 75 with 75 indicating best performance

    5 years

Eligibility Criteria

Age6 Hours - 1 Week
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • families unwilling to sign consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico gemelli

Rome, Italy

RECRUITING

Study Officials

  • Eugenio Mercuri

    F Policlinico Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenio Mercuri, MD

CONTACT

+39 063015eugeniomaria.mercuri@policlinicogemelli.it

Marika Pane, MD

CONTACT

063015marika.pane@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 16, 2023

Study Start

September 1, 2021

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

only aggregate data as from consensus

Locations

IT(1)