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NCT Number: NCT07533162

Modular Neurological Examination for Early Risk Detection

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Refusal to provide informed consent.
  • Inability to undergo the neurological examination due to clinical conditions that prevent its administration.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Application of the Modular Neurological Examination in the Early Identification of Children at Risk for Neurological Pathologies

Acronym: NEUROMODU

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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