Status:
COMPLETED
Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Complex Congenital Heart Disease
Eligibility:
All Genders
Up to 1 years
Brief Summary
Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply
Detailed Description
Cerebral protection is a major issue in the treatment of neonates and infants with complex congenital heart disease, because most common long-term morbidities of newborn heart surgery are related not ...
Eligibility Criteria
Inclusion
- term (37-42 weeks gestation) newborns
- pre- or postnatally diagnosed critical congenital heard disease (CHD)
- admitted to the pediatric cardiac intensive care unit at the Children's Hospital of Tübingen
Exclusion
- birth weight \<2 kg
- history of neonatal depression (5-min APGAR\<5, cord blood pH\<7.0, sepsis, or birth asphyxia)
- perinatal seizures
- evidence of end-organ injury
- preoperative cardiac arrest
- significant preoperative intracerebral hemorrhage such as grade 3 or 4 intraventricular hemorrhage.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04810013
Start Date
June 1 2020
End Date
November 30 2023
Last Update
December 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Univeristy Children's Hospital
Tübingen, Germany, 72076