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

Completed

• Conditions: Complex Congenital Heart Disease

• Registration Number: NCT04810013
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-22
• Status Verified: 2022-05
• Primary Completion: 2022-12-31
• Study Completion: 2023-11-30
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Range of mean arterial blood pressure	4within 8 hours after cardiac surgery at the PICU	Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT)

Secondary Outcome Measures

Name	Time	Method
Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation	within 8 hours after cardiac surgery at the PICU	Analysis of the influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation.Association between cFTOE and cerebral autoregulation indices (COx and HVx).
Influence of changed arterial oxygen saturation on cerebral autoregulation	within 8 hours after cardiac surgery at the PICU	Analysis of the influence of changed arterial oxygen saturation on cerebral autoregulation. Association between arterial SPO2 (%) and cerebral autoregulation indices (COx and HVx).
Neurological outcome measure	at age of 2 years	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.
Detection of severe brain injury	before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge	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
Influence of changed arterial blood pressure on cerebral autoregulation	within 8 hours after cardiac surgery at the PICU	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).
Influence of changed blood hemoglobin concentration on cerebral autoregulation	within 8 hours after cardiac surgery at the PICU	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).

Trial Locations

Locations (1)

Univeristy Children's Hospital; 🇩🇪 Tübingen, Germany