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临床试验/NCT03572868
NCT03572868已完成不适用

Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Development Quotient.

研究概览

简要总结

The decreased cerebellar biometry during second and third trimester ultrasound examination is the main parameter to diagnoses cerebellar and pontocerebellar hypoplasia. Investigators already described that a transverse cerebellar diameter (TCD) below the 5th centile at second or third trimester scan is related to a high rate of fetal malformations, severe intrauterine restriction in growth, chromosomal anomalies and genetic disorders, therefore when facing a TCD below the 5th centile, patients should be referred for oriented sonogram, fetal MRI (Magnetic resonance imaging) and fetal karyotyping.

However, prenatal counseling in case of an isolated decreased cerebellar biometry remains challenging since there are no data in the literature regarding the neurodevelopmental outcome of these newborns. The aim of this work is to evaluate the neurodevelopmental outcome of newborns with a prenatal isolated decreased cerebellar biometry, in order to improve prenatal counseling.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 2nd or the 3rd trimester ultrasound examination realized at the hospital "Femme Mère Enfant" in Lyon between 2008 and 2015
  • Isolated Transverse cerebellar diameter <5th centile
  • Parents who received the information and did not object to participate to the study

排除标准

  • Decreased Transverse cerebellar diameter with associated malformations diagnosed during prenatal period
  • Family history of neurodevelopmental delay or cognitive impairment
  • Preterm delivery (< 28 WG)
  • Severe restriction in growth at birth (<3e centile)
  • Neonatal asphyxia (pH blood cord < 7)
  • Apgar score < 7 at 5 min of live with transfer to the neonatal intensive care unit

结局指标

主要结局

Development Quotient.

时间窗: between 3 and 10 years after birth

Development Quotient of each child established from CDI questionnaire (Child Development Inventory).

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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