Cerebral perfusion during neonatal cardiac surgery: Can we improve outcome?

Cerebral perfusion during neonatal cardiac surgery: Can we improve outcome? - Immunological and cerebral effects of neonatal cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35580

Enrollment

Registered

2008-11-11

Start date

2009-02-03

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic arch reconstructions congenital heart disease

Interventions

One group will receive DHCA and the other group will receive ACP.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Infants (

Exclusion criteria

Exclusion criteria: Children that: - have objective evidence of infection - have failed to have tissue or laboratory data collected - participate in another clinical trial - have an expected longer duration of aortic arch reconstruction than 60 minutes - need to be sedated and intubated especially for the pre-operative MRI scan of this research project

Design outcomes

Primary

Measure	Time frame
Percentage of infants with new or worsened lesions on the postoperative MRI (compared to the preoperative MRI-scan).	—

Secondary

Measure	Time frame
- Cerebral damage: o Serum markers: Average of S100beta 4, 24 hours and 1 week postoperatively o aEEG monitoring: The average duration postoperatively, after which the aEEG returns to a normal pattern o NIRS: The average postoperative duration of NIRS-values	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)