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临床试验/NCT04889027
NCT04889027已完成不适用

Turkish Validity and Reliability of Standardized Infant NeuroDevelopmental Assessment

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Standardized Infant NeuroDevelopmental Assessment

研究概览

简要总结

This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.

详细描述

There are developments in the field of diagnosing children with a high risk of developmental disorders such as cerebral palsy (CP), mental problems and autism spectrum disorder in infancy. In particular, in infants experiencing the onset of extrauterine life in the neonatal intensive care unit, the combination of neonatal neuroimaging along with the assessment of general movements results in a highly accurate prediction of CP .

A clinical tool often used in predictions is a neurological examination. Various standard variants are available, such as the Hammersmith Infant Neurological Examination (HINE), Alberta Infant Motor Scale (AIMS).

The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome .This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.

研究设计

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

入排标准

年龄范围
1 Month 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • at-risk infants
  • discharged from neonatal intensive care unit;
  • age between 0 - 24 months old (corrected age for premature infants);
  • having a family acceptance for the participation

排除标准

  • having congenital anomalies,
  • musculoskeletal disorders,
  • cyanotic congenital heart disease and
  • mechanical dependency

结局指标

主要结局

Standardized Infant NeuroDevelopmental Assessment

时间窗: 20-30 minutes

The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome

次要结局

  • Hammersmith Infant Neurological Examination (HINE)(30-40 minutes)
  • Alberta Infant Motor Scale (AIMS).(30-45 minutes)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nilay Comuk Balci

Pt, PhD, Associate Professor

Ondokuz Mayıs University

研究点 (1)

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