Noninvasive Measurement of the Cerebral Autoregulation in Neonates and Infants With Complex Congenital Heart Disease

University Hospital Tuebingen

Status: Completed

Conditions: Complex Congenital Heart Disease

Treatments: Procedure: non-invasive measurement of cerebral autoregulation

Study type: Observational

Funder types: Other

Identifiers

NCT04810013

CAR_FN_01

Details and patient eligibility

About

Feasibility of non-invasive cerebral autoregulation measurement at the PICU and impact of changes in oxygen supply

Full 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.

Enrollment: 80 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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.