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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Complex Congenital Heart Disease

Intervention / Treatment
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* Procedure: non-invasive measurement of cerebral autoregulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: non-invasive measurement of cerebral autoregulation|Non-invasive measurement of the cerebral autoregulation in the postoperative period in 80 neonates and infants with complex congenital heart disease undergoing cardiopulmonary bypass surgery. A continuous, moving Pearson's correlation coefficient will be calculated between the arterial pressure and near-infrared spectroscopy signals and displayed continuously during surgery using a laptop computer and the ICM+ software (Cambridge Enterprise).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of mean arterial blood pressure | Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT) | 4within 8 hours after cardiac surgery at the PICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of severe brain injury | Detection of cerebral haemorrhage grade III or IV, cystic periventricular leukomalacia, cerebellar haemorrhage, post-haemorrhagic ventricular dilatation or cerebral atrophy) on routinely performed serial cranial ultrasound scans | before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge | 
| Neurological outcome measure | Landmarks of development score (Grenzsteine der Entwicklung Score) aus (Monatsschr Kinderheilkd_2013 · 161:898-910_· DOI 10.1007/s00112-012-2751-0 © Springer-Verlag Berlin Heidelberg 2013 R._Michaelis_· R._Berger_· U._Nennstiel-Ratzel_· I._Krägeloh-Mann Validierte und teilvalidierte Grenzsteine der Entwicklung). The score uses dichotomous questions, that asks for a Yes/No response. The score consists of a total of 16 questions, the more questions answered yes, the better the outcome and vice versa. Minimum value is n=0 yes and n=16 no answers, maximum value is n=16 yes and n=0 no answers. | at age of 2 years | 
| Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation | Analysis of the influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation.Association between cFTOE and cerebral autoregulation indices (COx and HVx). | within 8 hours after cardiac surgery at the PICU | 
| Influence of changed arterial blood pressure on cerebral autoregulation | Analysis of the influence of changed arterial blood pressure on cerebral autoregulation. Association between arterial blood pressure (mmHg) and cerebral autoregulation indices (COx and HVx). | within 8 hours after cardiac surgery at the PICU | 
| Influence of changed arterial oxygen saturation on cerebral autoregulation | Analysis of the influence of changed arterial oxygen saturation on cerebral autoregulation. Association between arterial SPO2 (%) and cerebral autoregulation indices (COx and HVx). | within 8 hours after cardiac surgery at the PICU | 
| Influence of changed blood hemoglobin concentration on cerebral autoregulation | 4. Analysis of the influence of changed blood hemoglobin concentration on cerebral autoregulation. Association between arterial hemoglobin value (g/dL) and cerebral autoregulation indices (COx and HVx). | within 8 hours after cardiac surgery at the PICU |