Monitoring cerebral blood flow in newborns during heart surgery
Cerebral Blood Flow in Neonates During Major Cardiac- and Non-cardiac Surgery
UMC Utrecht · NCT04713605
This study looks at how blood flow to the brain changes in newborns during heart surgery to see if keeping it at the right level can help prevent brain damage after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | N/A to 6 Weeks |
| Sex | All |
| Sponsor | UMC Utrecht (other) |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT04713605 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess cerebral blood flow velocity (CBFV) in neonates undergoing major cardiac surgery to prevent postoperative brain damage. By measuring CBFV using transcranial Doppler (TCD) alongside invasive arterial blood pressure, the study seeks to establish patient-specific thresholds for maintaining adequate cerebral perfusion. The goal is to understand the relationship between perioperative blood pressure abnormalities and subsequent neurobehavioral outcomes in these vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates include term infants under 42 days old or preterm infants over 32 weeks corrected age undergoing elective cardiac or major non-cardiac surgery.
Not a fit: Patients with severe intracranial hemorrhage or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing brain damage in neonates undergoing cardiac surgery.
How similar studies have performed: While the approach of monitoring cerebral blood flow in this context is critical, similar studies have shown varying degrees of success in understanding cerebral perfusion in neonates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Term infant aged \< 42 days / Preterm born \> 32 weeks and with a corrected age \< 42 days * (Semi-) elective cardiac of major non-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.
Where this trial is running
Utrecht
- UMC Utrecht / Wilhelmina Children's Hospital — Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Kim van Loon, MD, PhD — University Medical Center Utrecht / Wilhelmina Children's Hospital
- Study coordinator: Sylvia van Rossum
- Email: S.M.vanRossum-5@umcutrecht.nl
- Phone: +31887561101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoperfusion in Newborn With Congenital Heart Disease, TCD, hypoperfusion, critical closing pressure