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Clinical Trials/NL-OMON34367
NL-OMON34367
Completed
Not Applicable

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

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Diaphragmatic Hernia
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
120
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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