Cerebral blood flow in neonates during cardiac- and major noncardiac surgery.

Recruiting

Conditions: Cerebral blood flow
Critical Closing Pressure (CrCP)
10010394
10007593

Registration Number: NL-OMON54127

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Term infant aged < 42 days / Preterm born > 32 weeks and with a corrected age
< 42 days
- (Semi-) elective cardiac surgery
- Routine placement of an arterial cannula for invasive blood pressure
monitoring.

Exclusion Criteria

- Grade III-IV intracranial hemorrhage.
- Emergency surgery or semi-elective surgery performed out of hours.
- Informed consent from the parents is not obtained.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint is the Critical Closing Pressure (CrCP) within and between<br /><br>subjects.<br /><br>Detection of the critical closing pressure (CrCP) of the brain, the arterial<br /><br>blood pressure at which brain vessels collapse and cerebral blood flow ceases,<br /><br>in a cohort of neonates who need major cardiac and non-cardiac surgery. We<br /><br>hypothesize that neonates have a unique CrCP and cerebral ischemia occurs<br /><br>during episodes with critically endangered blood supply to the brain, when the<br /><br>arterial blood pressure (iABP) is below CrCP. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Lower Limit of Autoregulation (LLA)<br /><br>- Intraoperative blood pressure variation<br /><br>- Mean CrCP difference between neonates with absent and new WMI on the<br /><br>postoperative MRI<br /><br>- Description and number of cerebral hypoperfusion events (iABP < CrCP) per<br /><br>unit of time.<br /><br>- Number of events with reversed cerebral flow (resistive index > 1) per unit<br /><br>of time.<br /><br>- Gaseous microemboli (GME) volumes and counts<br /><br>- Description of venous CBF patterns and incidence of abnormal cerebral venous<br /><br>return.<br /><br>- Detection of postoperative hyperperfusion</p><br>