Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Children who have undergone cardiac surgery are at high risk of neurological disability. Adequate cerebral perfusion during the surgery is paramount to minimise the risk of brain injury which is a well-documented complication. Whilst this is easily identifiable through brain imaging post-operatively, less is known about intracerebral vascular reactivity that arise due to inadequate cerebral perfusion during and immediately following surgery which may result in long-term neurological deficits. Some of these changes have been observed solely through long term evaluation of childhood behaviours, as is seen in the Boston Circulatory Arrest Trial.

Aortic arch surgical repair surgery is performed in acynotic patients with conditions like Hypoplastic Aortic Arch or Interrupted Aortic Arch, or in cyanotic patients for diagnosis such as Hypoplastic Left Heart Syndrome, where a single ventricle repair is undertaken by means of a Norwood type operation.

Aortic arch surgery is performed with the aid of cardiopulmonary bypass and requires stopping the body's circulation for the time employed to repair the aortic arch. In order to provide protection to the body and to the brain, the patient's temperature is reduced to 18-25C to minimise metabolic requirements. This is particularly important for the brain so circulation can be stopped while operating on the aortic arch in a bloodless field. In recent years, techniques aimed at preserving brain perfusion during circulatory arrest have been developed. Antegrade cerebral perfusion of cold blood (18-25C) via the right internal carotid artery has been successfully employed and it is routinely used at Alder Hey Children's Hospital. Nevertheless, target brain temperature, the rate of cooling, perfusion pressure and PCO2 in arterial blood significantly influence cerebral vascular reactivity and perfusion. The optimal temperature to ensure neuroprotection is currently unknown and the temperature for cooling is based on surgeon preference rather than solid evidence.

Currently, clinical practice in the UK is to employ near infrared spectroscopy (NIRS) as an index of cerebral perfusion. Whilst this is a simple and non-invasive tool, it only measures oxygen levels in the frontal lobes, and is purely indicative of oxygenation, not absorption of oxygen by the cerebral tissue. An injured brain will continue to show normal levels of saturation on NIRS despite hypoxia (lack of oxygen) induced injury. Novel imaging techniques are now available that can provide more in-depth information on real time cerebral perfusion and quantify the magnitude of changes during and following surgery in children. One research study has employed Transcranial Doppler to monitor cerebral velocity during aortic arch surgery whilst on cardiopulmonary bypass with the aim of maintaining cerebral velocity during surgery at a level similar to before cooling. More recently, duplex ultrasound to image the cerebral vessels through the fontanelle has been employed to obtain perfusion data from both hemispheres of the brain during aortic arch surgery. Taken together, these measurement techniques provide unique novel insight into the cerebrovascular changes which occur during the surgical and post-operative period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03047876
Study type Observational
Source Alder Hey Children's NHS Foundation Trust
Contact Attilio Lotto
Phone 0151 228 4811
Email attilio.lotto@alderhey.nhs.uk
Status Not yet recruiting
Phase
Start date March 1, 2020
Completion date March 19, 2021

See also
  Status Clinical Trial Phase
Withdrawn NCT01953562 - Positioning and the Spontaneous Breathing Test in Neonates N/A
Completed NCT03716882 - Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification
Recruiting NCT06353841 - Effect of Therapeutic Touch on Functional Constipation in Infants and Young Children N/A
Completed NCT06447558 - The Effects of "Oral Administration of Breast Milk Droplets" and "Palatal Stimulation With a Finger" N/A
Recruiting NCT05705258 - A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)
Not yet recruiting NCT06319079 - Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition N/A
Completed NCT02119104 - Prevenar (13v) Infant Drug Use Investigation N/A
Recruiting NCT06318858 - Daily and Weekly Iron Supplementation in Infants N/A
Withdrawn NCT05266677 - DHA Proof-of-Concept Study in Infants and Toddlers N/A
Recruiting NCT05940688 - Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study N/A
Not yet recruiting NCT06127914 - Learning Early Infant Feeding Cues N/A
Completed NCT05492253 - First Complementary Foods and the Infant Gastrointestinal Microbiota N/A
Completed NCT03327415 - Nutri-Bébé 2013 Survey on Food Consumption of Infants and Young Children N/A
Completed NCT04598841 - Nutrition Support for Hirschsprung Disease N/A
Completed NCT01664234 - Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children N/A
Terminated NCT02069522 - Healthy Term Infants Fed Milk-Based Formulas N/A
Completed NCT04218929 - Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants N/A
Recruiting NCT01575184 - Effect of Shoulder Traction on Size and Relative Position of Internal Jugular Vein to Carotid Artery N/A
Not yet recruiting NCT05994417 - Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants