跳至主要内容
临床试验/NCT07533162
NCT07533162进行中(未招募)不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Modular Neurological Examination

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Modular Neurological Examination

时间窗: From enrollment to the end of follow-up at 2 years

Modular Neurological Examination for Early Risk Detection

Hammersmith Neonatal Neurological Examination (HNNE)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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