Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
NCT Number: NCT07533162
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.
This study is active but is not currently recruiting participants.
Notify MeUp to 2 year
All sexes
Observational
Roma, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Application of the Modular Neurological Examination in the Early Identification of Children at Risk for Neurological Pathologies
Acronym: NEUROMODU
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