Congenital Heart DiseaseNCT00399555
Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
An observational study of Congenital Heart Disease, run by Emory University at 1 site in United States.
Trial summary
There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer. Because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in… Read more about this study
- Who is it for?
- Ages 29 months to 6 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jul 2009
- 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 29 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ages 2.5 to 6 years old who have hypoplastic left heart syndrome with surgical palliation and near infrared spectrometry monitoring during the Stage I Norwood procedure.
Who may be able to join
- Hypoplastic left heart syndrome is defined as normal segmental anatomy with mitral and/or aortic atresia or stenosis and a left ventricle too small to sustain the systemic circulation
- Ages 2.5 to 6 years old
- Surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001
Who cannot join
- Primary language in the home is not English
- Named genetic syndrome associated with profound developmental delay, such as DiGeorge Syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome-Correlation With Cerebral Non-invasive Infrared Spectroscopy (NIRS)
There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer. Because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in children with hypoplastic left heart syndrome. The purpose of this research study is to help the investigators learn more about developmental disabilities in children with hypoplastic left heart syndrome.
During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor was placed on your child's forehead to measure the oxygen levels in the brain. This monitor is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to know if oxygen levels in the blood vessels of the brain have any effect on developmental disabilities later in life in children with hypoplastic left heart syndrome. The researchers plan to enroll 60 research subjects.
Read the detailed description
Our study is a cross-sectional, descriptive study to evaluate the developmental outcome for school-age children with HLHS. The general approach of the proposed research is confirmatory study/hypothesis testing. The hypothesis (neurodevelopmental outcome of children with HLHS is inversely correlated with cerebral oximetry values as measured by NIRS in the 48 hours following the Norwood operation) was formulated based on a meticulous review of the literature, which clearly demonstrates a substantial prevalence of neurodevelopmental deficits in children with HLHS who have undergone surgical palliation. The methodologies for measuring developmental outcome are highly reproducible and have been validated in this population.
- Conditions
- Congenital Heart Disease
- Keywords
- Single Ventricle, Hypoplastic Left Heart, Developmental
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart, Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| One | Patients with HLHS that have had surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001. These patients must be between the ages of 2.5 years and 6 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the developmental outcome of school-age children with HLHS who have undergone the Norwood procedure at our institution after January 1, 2001
Measured: Ages 2.5 years to 6 years
Secondary outcomes (1)
Determine whether there is a correlation between cerebral oxygen levels as measured by NIRS and subsequent developmental outcome
Measured: NIRS measurement 48 hours after Norwood procedure and developemental outcome by 2.5-6 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William T. Mahle, MD, Emory University
- Investigators
- William Mahle, MD, Study director, Sibley Heart Center/Emory Universtiy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399555
- Sponsor's protocol ID
- IRB00000275
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2006
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome-Correlation With Cerebral Non-invasive Infrared Spectroscopy (NIRS)
- ClinicalTrials.gov ID
- NCT00399555
- Acronym / sponsor ID
- IRB00000275
- Conditions
- Congenital Heart Disease
- Keywords
- Single Ventricle, Hypoplastic Left Heart, Developmental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Nov 2006 (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.
There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer. Because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in children with hypoplastic left heart syndrome. The purpose of this research study is to help the investigators learn more about developmental disabilities in children with hypoplastic left heart syndrome.
During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor was placed on your child's forehead to measure the oxygen levels in the brain. This monitor is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to know if oxygen levels in the blood vessels of the brain have any effect on developmental disabilities later in life in children with hypoplastic left heart syndrome. The researchers plan to enroll 60 research subjects.
Detailed description
Our study is a cross-sectional, descriptive study to evaluate the developmental outcome for school-age children with HLHS. The general approach of the proposed research is confirmatory study/hypothesis testing. The hypothesis (neurodevelopmental outcome of children with HLHS is inversely correlated with cerebral oximetry values as measured by NIRS in the 48 hours following the Norwood operation) was formulated based on a meticulous review of the literature, which clearly demonstrates a substantial prevalence of neurodevelopmental deficits in children with HLHS who have undergone surgical palliation. The methodologies for measuring developmental outcome are highly reproducible and have been validated in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One | – | –Patients with HLHS that have had surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001. These patients must be between the ages of 2.5 years and 6 years of age. |
Who may qualify
- Ages
- 29 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ages 2.5 to 6 years old who have hypoplastic left heart syndrome with surgical palliation and near infrared spectrometry monitoring during the Stage I Norwood procedure.
Key inclusion criteria (3 listed)
- Hypoplastic left heart syndrome is defined as normal segmental anatomy with mitral and/or aortic atresia or stenosis and a left ventricle too small to sustain the systemic circulation
- Ages 2.5 to 6 years old
- Surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001
Key exclusion criteria (2 listed)
- Primary language in the home is not English
- Named genetic syndrome associated with profound developmental delay, such as DiGeorge Syndrome
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
To describe the developmental outcome of school-age children with HLHS who have undergone the Norwood procedure at our institution after January 1, 2001
Time frame: Ages 2.5 years to 6 years
1 secondary outcome
Determine whether there is a correlation between cerebral oxygen levels as measured by NIRS and subsequent developmental outcome
Time frame: NIRS measurement 48 hours after Norwood procedure and developemental outcome by 2.5-6 years of age
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 27 Nov 2013.
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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.
William Mahle, MD study director
Sibley Heart Center/Emory Universtiy School of Medicine
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 Congenital Heart Disease, run by Emory University 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 3 inclusion and 2 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 27 Nov 2013. 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.
What does the primary outcome measure?
To describe the developmental outcome of school-age children with HLHS who have undergone the Norwood procedure at our institution after January 1, 2001 (time frame: Ages 2.5 years to 6 years). It is what the study was designed to measure, not a finding.
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 27 Nov 2013.