Neonatal EncephalopathyNCT05772416
Neonatal Neurological Examination to Detect Infants at Risk
An observational study of Neonatal Encephalopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 6 hours to 1 week
- Conditions the study is for
- Neonatal Encephalopathy
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 hours to 1 week
- All sexes
- 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
Who may be able to join
- all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions
Who cannot join
- families unwilling to sign consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico gemelli
Rome
Eugenio Mercuri, 063015 ext. 5340, eugeniomaria.mercuri@policlinicogemelli.it
About this study
Official title: Diagnostic Value of the Neonatal Neurological Examination to Detect Infants at Risk for Neurological Abnormalities
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.
Read the 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.
- Conditions
- Neonatal Encephalopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Hammersmith Neonatal and infant Neurological examination
neurological examination witha score from 0 to 75 with 75 indicating best performance
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Sep 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal EncephalopathyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenio Mercuri, Principal investigator, F Policlinico Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772416
- Sponsor's protocol ID
- 4313
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only aggregate data as from consensus
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of the Neonatal Neurological Examination to Detect Infants at Risk for Neurological Abnormalities
- ClinicalTrials.gov ID
- NCT05772416
- Acronym / sponsor ID
- 4313
- Conditions
- Neonatal Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 hours to 1 week
- Sex
- All
- Age groups
- 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
Key inclusion criteria (1 listed)
- all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions
Key exclusion criteria (1 listed)
- families unwilling to sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hammersmith Neonatal and infant Neurological examination
Time frame: 5 years
neurological examination witha score from 0 to 75 with 75 indicating best performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No. only aggregate data as from consensus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenio Mercuri principal investigator
F Policlinico Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Encephalopathy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugenio Mercuri, MD (+39 063015 ext. 5340, eugeniomaria.mercuri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hammersmith Neonatal and infant Neurological examination (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.