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临床试验/NCT04073836
NCT04073836Unknown不适用

Early Detection of the Cerebral Palsy in Moderate and Late Preterms Through the General Movements

University of Castilla-La Mancha1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
gestation weeks

研究概览

简要总结

To analyze the relationship between the early diagnosis of cerebral palsy with the risk factors of this pathology in moderate and late premature infants

详细描述

Analyze a sample of moderate and late premature infants using general movements and verify which of them would have an early diagnosis of cerebral palsy and relate it to their risk factors for this pathology.

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
32 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Subjects who were born between the week 32 + 0 days and the week 36 + 6 days and who are admitted to the Hospital Nuestra Señora del Prado de Talavera de la Reina or the Hospital Virgen de la Salud de Toledo.

排除标准

  • Any type of pre and perinatal diagnostic neurological involvement.
  • Any type of pathology associated with prematurity.
  • Children who have prescribed any of the following medications (10):
  • Barbiturates
  • Antiepileptic
  • Indomethacin
  • Dexamethasone

结局指标

主要结局

gestation weeks

时间窗: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

Premature birth week

weight

时间窗: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

measurement, World Health Organization percentile

size

时间窗: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

measurement, World Health Organization percentile

Magnetic resonance imaging rating scale

时间窗: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

Outcome about Neuroimaging in preterms

cranial perimeter

时间窗: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

measurement about head, World Health Organization percentile

Apgar

时间窗: at birth of each preterm

Outcome about Apgar Test

general movements outcome

时间窗: From date of Recruiting until the discharging of neonatal intensive care unit, assessed up to 40 weeks

Outcome about General Movements Assessment. Three outcomes about movement of preterm. Normal, Poor Repertoire and Cramped Synchronized

PERI outcome

时间窗: through study completion, an average of 18 months

Outcome about Perinatal Risk Scale Scale. Minimum score: 0. Maximum score: 51

次要结局

未报告次要终点

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (1)

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