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临床试验/NL-OMON34367
NL-OMON34367已完成不适用

ongitudinal microcirculatory changes in newborns with Congenital Diaphragmatic Hernia; an observational study - Microcirculatory changes in CDH

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
2 至 11(—)

入选标准

  • Group 1: CDH patients
  • - Antenatal diagnosis of CDH
  • - Mother admitted to Obstetrics & Gynecology department, Erasmus MC-Sophia
  • - Parental informed consent ;Group 2: Control patients
  • - Control patients for group 1, matched for gender, PMA (±1 week) and age (± 1 day).
  • - Admittance to IC of Erasmus MC-Sophia
  • - Congenital malformations of the digestive tract
  • - Parental informed consent;Group 2B
  • - Control patients for group 1, matched for gender, PMA (±1 week) and age (± 1 day).
  • - Born in the Obstetrics & Gynecolgy department of Erasmus MC-Sophia
  • - Mother admitted to the Obstetrics & Gynecolgy department of Erasmus MC-Sophia
  • - Parental informed consent

排除标准

  • Group 1: CDH patients
  • - Non-antenatal diagnosis of CDH
  • - Outborn CDH patients
  • - Recurrent CDH
  • - Lung pathology mimicking diagnostic or clinical signs of CDH (diseases which should be excluded are diaphragmatic eventration, congenital cystic adenomatoid malformation (CCAML), bronchopulmonary sequestration, bronchogenic cysts, bronchial atresia, enteric cysts and teratomas)
  • - Severe chromosomal anomaly (i.e. trisomy 13 or trisomy 18), which imply abstinence of therapy
  • - Severe congenital cardiac anomaly (i.e. transposition of the great arteries, double outlet right ventricle, truncus arteriosus) with the exception of cardiac deformations associated with CDH (i.e. PDA, patent foramen ovale (PFO), small atrioventricular (AVSD) or atrioseptal defect (ASD))
  • - Cardiopulmonary resuscitation and subsequent therapeutic hypothermia;Group 2: Control patients
  • Group 2A & Group 2B
  • - Congenital anomalies or pathology of any kind known to influence cardiorespiratory functioning
  • - Use of vasopressor(s) (i.e. dobutamine, dopamine, epinephrine, norepinephrine) and/or iNO therapy

研究者

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