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

NCT04810013 | Completed

• 1 other identifier: CAR_FN_01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complex Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Detection of severe brain injury

  before surgery, 12 hours, 48 hours, 72 hours post surgery and before discharge

• Neurological outcome measure

  at age of 2 years

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

  within 8 hours after cardiac surgery at the PICU

• Influence of changed arterial blood pressure on cerebral autoregulation

  within 8 hours after cardiac surgery at the PICU

• Influence of changed arterial oxygen saturation on cerebral autoregulation

  within 8 hours after cardiac surgery at the PICU

Interventions

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).

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborns

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Univeristy Children's Hospital

Tübingen, 72076, Germany

Location

Study Officials

• Felix Neunhoeffer

  University Children's Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: November 30, 2023
• Last Updated: December 21, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)