Infants Clinical Trial
Official title:
Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery in Neonates and Infants.
Many neonates and infants who undergo complex cardiac surgery are affected by neurological
developmental delays. Whilst catastrophic events are immediately identifiable from clinical
examination or by macro changes on MRI or CT scans, smaller changes are often not immediately
visible or detected.
This is an observational pilot study examining brain vascular reaction to hypothermic
circulatory arrest with antegrade cerebral perfusion and neuro-protection techniques during
aortic arch surgery in neonates and infants. A combination of duplex ultrasound and
transcranial doppler will be used to record in-depth information on the cerebrovascular
changes that occur during the entire length of the surgical procedure and during the early
postoperative period. The proposed techniques and equipment are non-invasive and are in use
clinically to evaluate brain perfusion in a similar age group.
During aortic arch surgery, the patient's body and brain temperature is reduced to values
between 18 and 24 degrees centigrade in order to decrease metabolic demand that provides a
form of metabolic protection. However, there is no consensus within the clinical community
regarding the optimal temperature at which to perform surgery. Moreover, in order to improve
cerebral perfusion, the brain is perfused via the right internal carotid artery with cold
blood. At Alder Hey Children Hospital, this surgery is undertaken by the three surgeons but,
due to clinical preference, differs in relation to the temperature at which surgery is
undertaken. This provides the opportunity to observe the impact of different temperatures on
cerebral vascular reactivity in neonates and young infants The arguments for future
comparisons and a larger randomised study will be made based on the information gained from
this observational study.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 19, 2021 |
Est. primary completion date | March 19, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 1 Year |
Eligibility |
Inclusion Criteria: - All neonates and infants undergoing aortic arch surgery Exclusion Criteria: - Procedures undertaken as an emergency - Parents/guardians who do not wish for their child to participate - Parents/ guardians who are unable to provide written consent |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Alder Hey Children's Hospital | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Alder Hey Children's NHS Foundation Trust |
United Kingdom,
Andropoulos DB, Stayer SA, McKenzie ED, Fraser CD Jr. Regional low-flow perfusion provides comparable blood flow and oxygenation to both cerebral hemispheres during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 2003 Dec;126(6):1712-7. — View Citation
Gaynor JW, Stopp C, Wypij D, Andropoulos DB, Atallah J, Atz AM, Beca J, Donofrio MT, Duncan K, Ghanayem NS, Goldberg CS, Hövels-Gürich H, Ichida F, Jacobs JP, Justo R, Latal B, Li JS, Mahle WT, McQuillen PS, Menon SC, Pemberton VL, Pike NA, Pizarro C, Shekerdemian LS, Synnes A, Williams I, Bellinger DC, Newburger JW; International Cardiac Collaborative on Neurodevelopment (ICCON) Investigators. Neurodevelopmental outcomes after cardiac surgery in infancy. Pediatrics. 2015 May;135(5):816-25. doi: 10.1542/peds.2014-3825. — View Citation
McCrindle BW, Tchervenkov CI, Konstantinov IE, Williams WG, Neirotti RA, Jacobs ML, Blackstone EH; Congenital Heart Surgeons Society. Risk factors associated with mortality and interventions in 472 neonates with interrupted aortic arch: a Congenital Heart Surgeons Society study. J Thorac Cardiovasc Surg. 2005 Feb;129(2):343-50. — View Citation
Rüffer A, Tischer P, Münch F, Purbojo A, Toka O, Rascher W, Cesnjevar RA, Jüngert J. Comparable Cerebral Blood Flow in Both Hemispheres During Regional Cerebral Perfusion in Infant Aortic Arch Surgery. Ann Thorac Surg. 2017 Jan;103(1):178-185. doi: 10.1016/j.athoracsur.2016.05.088. Epub 2016 Aug 23. — View Citation
Wypij D, Newburger JW, Rappaport LA, duPlessis AJ, Jonas RA, Wernovsky G, Lin M, Bellinger DC. The effect of duration of deep hypothermic circulatory arrest in infant heart surgery on late neurodevelopment: the Boston Circulatory Arrest Trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1397-403. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility Data | Quantify the impact of surgical and post-operative clinical intervention of aortic arch surgery on cerebral perfusion | 1 year |
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