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NCT Number: NCT04810013

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

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

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Key information

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy Children's Hospital

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-invasive measurement of cerebral autoregulation

Procedure

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).

Primary outcomes

  1. Range of mean arterial blood pressure

    Time frame: 4within 8 hours after cardiac surgery at the PICU

    Measurement of the range of mean arterial blood pressure (MAP) with optimal vasoreactivity (MAPOPT)

Secondary outcomes

  1. Detection of severe brain injury

    Time frame: 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

  2. Neurological outcome measure

    Time frame: 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.

  3. Influence of changed fractional cerebral oxygen extraction (cFTOE) on cerebral autoregulation

    Time frame: 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).

  4. Influence of changed arterial blood pressure on cerebral autoregulation

    Time frame: 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).

  5. Influence of changed arterial oxygen saturation on cerebral autoregulation

    Time frame: 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).

  6. Influence of changed blood hemoglobin concentration on cerebral autoregulation

    Time frame: within 8 hours after cardiac surgery at the PICU

    • 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).

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 22, 2021
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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