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

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)

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

Study Overview

• Status: Completed
• Conditions: Complex Congenital Heart Disease
• Intervention / Treatment: Procedure: non-invasive measurement of cerebral autoregulation

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Univeristy Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Newborns

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Felix Neunhoeffer, University children's hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: CAR_FN_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No