Hypoplastic Left Heart SyndromeNIRS-NDNCT00464100
Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes
An observational study of Hypoplastic Left Heart Syndrome, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoplastic Left Heart Syndrome
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2006to 4 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Cases: * clinical diagnosis of hypoplastic left heart syndrome, status post Norwood procedure, bidirectional Glenn, and completion Fontan, ages 4-5 years old, English-speaking patient and parent, informed consent Controls: Healthy children 4-5 years old, English-speaking patient and parent, informed consent
Who may be able to join
- Cases:
- clinical diagnosis of hypoplastic left heart syndrome, status post Norwood procedure, bidirectional Glenn, and completion Fontan, ages 4-5 years old, English-speaking patient and parent, informed consent
- Controls:
- Healthy children 4-5 years old, English-speaking patient and parent, informed consent
Who cannot join
- Congenital or acquired abnormality associated with neurologic morbidity independent of cardiac lesion
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Neurodevelopmental Outcomes and Postoperative Hemodynamics in Children With Hypoplastic Left Heart Syndrome
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.
Read the detailed description
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.
- Conditions
- Hypoplastic Left Heart Syndrome
- Keywords
- Neurodevelopmental outcomes, congenital heart disease, NIRS monitoring, hypoxia
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Heart Defects, Congenital, Hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study start1 Mar 2006
- Primary completion4 Dec 2013
- Study completion4 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Nancy Ghanayem, Medical College of Wisconsin
- Investigators
- Nancy Ghanayem, MD, Principal investigator, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464100
- Sponsor's protocol ID
- CHW 06/36
- Acronym
- NIRS-ND
- Status last verified
- Aug 2019
- First submitted
- 18 Apr 2007
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcomes and Postoperative Hemodynamics in Children With Hypoplastic Left Heart Syndrome
- ClinicalTrials.gov ID
- NCT00464100
- Acronym / sponsor ID
- NIRS-ND / CHW 06/36
- Conditions
- Hypoplastic Left Heart Syndrome
- Keywords
- Neurodevelopmental outcomes, congenital heart disease, NIRS monitoring, hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- 1 Mar 2006 (actual)
- Primary completion
- 4 Dec 2013 (actual)
- Study completion
- 4 Dec 2013 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Cases: * clinical diagnosis of hypoplastic left heart syndrome, status post Norwood procedure, bidirectional Glenn, and completion Fontan, ages 4-5 years old, English-speaking patient and parent, informed consent Controls: Healthy children 4-5 years old, English-speaking patient and parent, informed consent
Key inclusion criteria (4 listed)
- clinical diagnosis of hypoplastic left heart syndrome, status post Norwood procedure, bidirectional Glenn, and completion Fontan, ages 4-5 years old, English-speaking patient and parent, informed consent
- Healthy children 4-5 years old, English-speaking patient and parent, informed consent
Key exclusion criteria (1 listed)
- Congenital or acquired abnormality associated with neurologic morbidity independent of cardiac lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
Related trials for Hypoplastic Left Heart Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Ghanayem, MD principal investigator
Children's Hospital and Health System Foundation, Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoplastic Left Heart Syndrome, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.