Clinical Practice GuidelinesNEUROMODUNCT07533162
Modular Neurological Examination for Early Risk Detection
An observational study of Clinical Practice Guidelines and Neurological Development, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Despite the availability of increasingly sophisticated instrumental examinations, the neurological assessment of the neonate and infant remains an effective, non-invasive, rapid, and cost-effective method for evaluating the integrity of the nervous system. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Clinical Practice Guidelines, Neurological Development
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2026to 30 Apr 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants followed by the Child Neuropsychiatry Service of the A. Gemelli University Hospital Foundation IRCCS
Who may be able to join
- Patients attending the Child Neuropsychiatry Service of the A. Gemelli University Hospital Foundation IRCCS, aged between 0 and 24 months.
- Patients whose parents/legal guardians have signed the informed consent form.
Who cannot join
- Refusal to provide informed consent.
- Inability to undergo the neurological examination due to clinical conditions that prevent its administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of the Modular Neurological Examination in the Early Identification of Children at Risk for Neurological Pathologies
Despite the availability of increasingly sophisticated instrumental examinations, the neurological assessment of the neonate and infant remains an effective, non-invasive, rapid, and cost-effective method for evaluating the integrity of the nervous system. It represents a fundamental component of the child's overall assessment, allowing for the early identification of risk factors for the development of neurological disorders. Although this examination is part of routine clinical practice, the methods by which it is performed are often suboptimal.
Over time, several attempts have been made to systematise the neurological examination through the development of standardised tools designed to assess both strictly neurological and behavioural aspects. The Hammersmith Neonatal Neurological Examination (HNNE) and the Hammersmith Infant Neurological Examination (HINE) currently represent the most widely used instruments in both clinical and research settings, providing an effective means for the early diagnosis of neurological sequelae in children at both low and high risk of neurological damage between 0 and 24 months of age.
Read more
Through a modular tool, which requires no more than 15 minutes to administer, it is possible to perform systematic screening with a validated instrument, thereby identifying patients who require further evaluation. In cases where this examination highlights suspicious clinical findings, additional tools can be employed to assess more specific aspects such as hypotonia or visual disorders.
This modular system, developed as a modification of a neurological examination already in worldwide use at our Centre and representing the gold standard reference for the present study, requires further validation in light of new paediatric care standards, which have evolved over the past 20 years since the validation of the original examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hammersmith Neonatal Neurological Examination (HNNE)
Modular Neurological Examination for Early Risk Detection. A score above 30.5 is considered normal, whereas a score below 30.5 is considered pathological.
Measured: From enrollment to the end of follow-up at 2 years
Hammersmith Infant Neurological Examination (HINE)
Modular Neurological Examination for Early Risk Detection. Global scores are reported as optimal if they are equal orabove 73 at 9 to 12 months, or equal or above 70 and 67 at 6 months and 3 months respectively.
Measured: From enrollment to the end of follow-up at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Feb 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Practice GuidelinesStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domenico Marco Romeo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533162
- Sponsor's protocol ID
- 17127
- Acronym
- NEUROMODU
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Modular Neurological Examination in the Early Identification of Children at Risk for Neurological Pathologies
- ClinicalTrials.gov ID
- NCT07533162
- Acronym / sponsor ID
- NEUROMODU / 17127
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 16 Apr 2026 (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.
Despite the availability of increasingly sophisticated instrumental examinations, the neurological assessment of the neonate and infant remains an effective, non-invasive, rapid, and cost-effective method for evaluating the integrity of the nervous system. It represents a fundamental component of the child's overall assessment, allowing for the early identification of risk factors for the development of neurological disorders. Although this examination is part of routine clinical practice, the methods by which it is performed are often suboptimal.
Over time, several attempts have been made to systematise the neurological examination through the development of standardised tools designed to assess both strictly neurological and behavioural aspects. The Hammersmith Neonatal Neurological Examination (HNNE) and the Hammersmith Infant Neurological Examination (HINE) currently represent the most widely used instruments in both clinical and research settings, providing an effective means for the early diagnosis of neurological sequelae in children at both low and high risk of neurological damage between 0 and 24 months of age.
Through a modular tool, which requires no more than 15 minutes to administer, it is possible to perform systematic screening with a validated instrument, thereby identifying patients who require further evaluation. In cases where this examination highlights suspicious clinical findings, additional tools can be employed to assess more specific aspects such as hypotonia or visual disorders.
This modular system, developed as a modification of a neurological examination already in worldwide use at our Centre and representing the gold standard reference for the present study, requires further validation in light of new paediatric care standards, which have evolved over the past 20 years since the validation of the original examination.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants followed by the Child Neuropsychiatry Service of the A. Gemelli University Hospital Foundation IRCCS
Key inclusion criteria (2 listed)
- Patients attending the Child Neuropsychiatry Service of the A. Gemelli University Hospital Foundation IRCCS, aged between 0 and 24 months.
- Patients whose parents/legal guardians have signed the informed consent form.
Key exclusion criteria (2 listed)
- Refusal to provide informed consent.
- Inability to undergo the neurological examination due to clinical conditions that prevent its administration.
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 Neurological Examination (HNNE)
Time frame: From enrollment to the end of follow-up at 2 years
Modular Neurological Examination for Early Risk Detection. A score above 30.5 is considered normal, whereas a score below 30.5 is considered pathological.
Hammersmith Infant Neurological Examination (HINE)
Time frame: From enrollment to the end of follow-up at 2 years
Modular Neurological Examination for Early Risk Detection. Global scores are reported as optimal if they are equal orabove 73 at 9 to 12 months, or equal or above 70 and 67 at 6 months and 3 months respectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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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.
Domenico Marco Romeo principal investigator
Fondazione Policlinico Universitario Agostino 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 Clinical Practice Guidelines and Neurological Development, 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hammersmith Neonatal Neurological Examination (HNNE) (time frame: From enrollment to the end of follow-up at 2 years). The study lists 2 primary outcomes in all. 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 21 Apr 2026.