An observational study in Hypoplastic Left Heart Syndrome, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 4 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by Medical College of Wisconsin · Observational
We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open heart operation, measured by things like blood pressure, oxygen saturation, heart rate and others, may have an impact on development. Studying how post-operative condition impacts outcomes may help us to protect babies better when they undergo surgery.
This study will look at some of the long-term outcomes of children with HLHS, including both mental development and quality of life. We will use information from your child's medical record to see if early oxygen delivery has an impact on later development.
Over the past twenty years, the field of congenital heart disease has been marked by globally improved survival after complex congenital heart surgery. These improved results are clearly multi-factorial and include advances in diagnostic technologies, surgical techniques, perfusion strategies, pharmacologic therapies and perioperative monitoring of tissue oxygen delivery.
Hypoplastic left heart syndrome (HLHS) represents an extreme form of complex congenital heart disease in which the infant has prolonged cyanosis and a single systemic right ventricle. Staged palliation beginning with surgery in the neonatal period is the most common approach to infants with HLHS. After initial surgical palliation, infants are critically ill due to ischemia/reperfusion injury from cardiopulmonary bypass, coronary ischemia attributed to diastolic runoff, reduced total ventricular mass, continued hypoxemia during a time of increased metabolic demands, and finally, the inherent inefficiency of parallel circulation. The presence of any one of these physiologic derangements places the infant with HLHS at great risk for ischemia, organ dysfunction, circulatory collapse and, even, death. Postoperative monitoring of venous oximetry and, more recently, near infrared spectroscopy, have identified periods of impaired oxygen delivery and ischemia, allowed for interventions that enhance oxygen delivery and improved survival after cardiac surgery. Although, an apparent relationship exists between oxygen delivery and survival after cardiac surgery, little data is available on the relationship between oxygen delivery and neurodevelopmental outcomes (inclusive of neurocognitive and neuropsychologic outcomes).
Preliminary data from our center has recently identified that reduced venous oximetry was associated with adverse neurodevelopmental outcome. These initial findings warrant further investigation of neurologic injury, specifically, how such morbidity relates to perioperative ischemia and cerebral oxygen delivery. Hence, the purpose of this study is to understand the relationship of perioperative tissue dysoxia and long-term neurodevelopmental morbidity in children subject to oxygen delivery at which neurodevelopment is compromised. Identification of a critical threshold that may be devastating to a child's neurodevelopment and quality of life would allow for early intervention, goal-directed therapy and ultimately, improve outcomes.
60 studies on the registry are indexed under Hypoplastic Left Heart Syndrome; 11 are open to participants now.
This study's enrollment of 48 is below the median of 111 across 20 observational studies indexed under Hypoplastic Left Heart Syndrome.
Browse Hypoplastic Left Heart Syndrome studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cases:
Controls:
Healthy children 4-5 years old, English-speaking patient and parent, informed consent
Cases:
Controls:
Healthy children 4-5 years old, English-speaking patient and parent, informed consent
Exclusion Criteria:
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hypoplastic Left Heart Syndrome→
Medical College of Wisconsin