Clinical trial NCT04810013: Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease
Official title: Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease After Cardiac Surgery With Cardiopulmonary Bypass at the Pediatric Intensive Care Unit (PICU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Congenital Heart Disease
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 80
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborns

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 to the heart, but instead to the cognitive challenges experienced by this population. Disruption of cerebral autoregulation in the postoperative period may contribute to brain injury in these patients. Blood pressure management, respirator management and red blood cell transfusion management after cardiopulmonary bypass surgery using endpoints such cerebral autoregulation monitoring might provide a method to optimize organ perfusion and improve neurologic outcome from cardiac surgery in the vulnerable postoperative period.

Primary Objectives: Feasibility of non-invasive cerebral autoregulation measurement at the PICU: Identification of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT), indicating intact cerebral autoregulation.

Secondary Objectives: Impact of decreased oxygen delivery, increased cerebral oxygen extraction, decreased cardiac output, arterial hypotension, severe hypoxemia and/or severe anemia on cerebral autoregulation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Range of mean arterial blood pressure
timeFrame: 4within 8 hours after cardiac surgery at the PICU
Secondary outcomes:
measure: Detection of severe brain injury
timeFrame: before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge
measure: Neurological outcome measure
timeFrame: at age of 2 years
measure: Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation
timeFrame: within 8 hours after cardiac surgery at the PICU
measure: Influence of changed arterial blood pressure on cerebral autoregulation
timeFrame: within 8 hours after cardiac surgery at the PICU
measure: Influence of changed arterial oxygen saturation on cerebral autoregulation
timeFrame: within 8 hours after cardiac surgery at the PICU
measure: Influence of changed blood hemoglobin concentration on cerebral autoregulation
timeFrame: within 8 hours after cardiac surgery at the PICU
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Univeristy Children's Hospital
Study officials:
affiliation: University Children's Hospital Tübingen
name: Felix Neunhoeffer
role: PRINCIPAL_INVESTIGATOR
References: