Congenital Heart DiseaseNCT01291797
Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study aims to examine performance on a neurological screening test, the Dubowitz, and sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. Read more about this study
- Who is it for?
- Ages 1 day to 2 months
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2011
- 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 1 day to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: Anticipated, 65 newborns with congenital heart disease and 20 newborns without congenital heart disease
Who may be able to join
- Newborn with cardiac anomaly requiring surgical intervention or a newborn that is in NICU for at least 24 hours for monitoring
- If newborn has congenital cardiac anomaly, cardiac repair must be performed at Mount Sinai Hospital
- If newborn has congenital cardiac anomaly, he/she must be managed pre-operatively for at least 24 hours at Mount Sinai Hospital
- If newborn has congenital cardiac anomaly, he/she must be managed post-operatively at Mount Sinai Hospital for at least 72 hours
Who cannot join
- Newborns with previously known anomalies other than cardiac
- Chromosomal abnormalities other than 22Q, that might have long-term neurodevelopmental implications
- Diagnosis of hypoxic-ischemic encephalopathy
- Metabolic disorder
- Other genetic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Hospital Division of Newborn Medicine
New York, New York, 10029
About this study
This study aims to examine performance on a neurological screening test, the Dubowitz, and sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. It will compare the results of these studies to neonates without CHD.
Read the detailed description
Neonates with congenital heart disease are at increased risk of adverse long term neurodevelopmental outcomes, including lower mean intelligent quotients (IQs). However, it is difficult to predict with neonates are most likely to be affected and a cost effective method is needed. AEEG has been used in neonates with hypoxic-ischemic encephalopathy and abnormal sleep wake cycles have been proposed to predict poorer long term outcomes. We thus hypothesize that abnormal sleep wake cycles in neonates with congenital heart disease will correlate with poorer outcomes. In our study, we will examine the relationship between performance on a neurodevelopmental screening tool, the Dubowitz neonatal neurological screening tool, and the sleep wake cycles on AEEG both before and after cardiac repair to try and predict which neonates are at increased risk of adverse long term outcomes. We will also compare the findings of the AEEG and performance on the neurodevelopmental tool to the data gathered from neonates without cardiac disease.
- Conditions
- Congenital Heart Disease
- Keywords
- congenital heart disease, neurodevelopmental outcome, AEEG, sleep wake cycles
- Medical subject headings
- Heart Defects, Congenital
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 |
|---|---|---|
| Neonates with congenital heart disease | The case group will consist of newborns born between 32 and 41 weeks gestation diagnosed with a congenital cardiac anomaly requiring surgical repair during their hospitalization and managed in the Mount Sinai Neonatal Intensive Care Unit. The control arm will include newborns born between 32 and 41 weeks without congenital cardiac anomalies. Both groups will undergo a neurological screening assessment and receive an AEEG to look at sleep wake cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal sleep wake cycles on AEEG
Measured: from 24 hours of life to time of discharge home from the neonatal intensive care unit (NICU) which is on average about four weeks
Secondary outcomes (6)
Performance on neurologic screening tools
Measured: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Head ultrasound abnormalities
Measured: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Seizures
Measured: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Death
Measured: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Inability to feed orally
Measured: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Respiratory support requirement
Measured: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: due to inability to recruit sufficient sample size in reasonable time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Ian Holzman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291797
- Sponsor's protocol ID
- MSSM 10-0568
- Status last verified
- Aug 2011
- First submitted
- 3 Feb 2011
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Massaro AN, El-Dib M, Glass P, Aly H. Factors associated with adverse neurodevelopmental outcomes in infants with congenital heart disease. Brain Dev. 2008 Aug;30(7):437-46. doi: 10.1016/j.braindev.2007.12.013. Epub 2008 Feb 4.
PubMed 18249516Brown MD, Wernovsky G, Mussatto KA, Berger S. Long-term and developmental outcomes of children with complex congenital heart disease. Clin Perinatol. 2005 Dec;32(4):1043-57, xi. doi: 10.1016/j.clp.2005.09.008.
PubMed 16325677Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.
PubMed 11060529Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
PubMed 12563063
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01291797
- Acronym / sponsor ID
- MSSM 10-0568
- Conditions
- Congenital Heart Disease
- Keywords
- congenital heart disease, neurodevelopmental outcome, AEEG, sleep wake cycles
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to inability to recruit sufficient sample size in reasonable time frame.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Feb 2011 (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.
This study aims to examine performance on a neurological screening test, the Dubowitz, and sleep wake cycles on amplitude integrated electroencephalogram (AEEG) in neonates with congenital heart disease (CHD) as a way to potentially predict longterm motor outcome. It will compare the results of these studies to neonates without CHD.
Detailed description
Neonates with congenital heart disease are at increased risk of adverse long term neurodevelopmental outcomes, including lower mean intelligent quotients (IQs). However, it is difficult to predict with neonates are most likely to be affected and a cost effective method is needed. AEEG has been used in neonates with hypoxic-ischemic encephalopathy and abnormal sleep wake cycles have been proposed to predict poorer long term outcomes. We thus hypothesize that abnormal sleep wake cycles in neonates with congenital heart disease will correlate with poorer outcomes. In our study, we will examine the relationship between performance on a neurodevelopmental screening tool, the Dubowitz neonatal neurological screening tool, and the sleep wake cycles on AEEG both before and after cardiac repair to try and predict which neonates are at increased risk of adverse long term outcomes. We will also compare the findings of the AEEG and performance on the neurodevelopmental tool to the data gathered from neonates without cardiac disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with congenital heart disease | – | –The case group will consist of newborns born between 32 and 41 weeks gestation diagnosed with a congenital cardiac anomaly requiring surgical repair during their hospitalization and managed in the Mount Sinai Neonatal Intensive Care Unit. The control arm will include newborns born between 32 and 41 weeks without congenital cardiac anomalies. Both groups will undergo a neurological screening assessment and receive an AEEG to look at sleep wake cycles. |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Anticipated, 65 newborns with congenital heart disease and 20 newborns without congenital heart disease
Key inclusion criteria (4 listed)
- Newborn with cardiac anomaly requiring surgical intervention or a newborn that is in NICU for at least 24 hours for monitoring
- If newborn has congenital cardiac anomaly, cardiac repair must be performed at Mount Sinai Hospital
- If newborn has congenital cardiac anomaly, he/she must be managed pre-operatively for at least 24 hours at Mount Sinai Hospital
- If newborn has congenital cardiac anomaly, he/she must be managed post-operatively at Mount Sinai Hospital for at least 72 hours
Key exclusion criteria (5 listed)
- Newborns with previously known anomalies other than cardiac
- Chromosomal abnormalities other than 22Q, that might have long-term neurodevelopmental implications
- Diagnosis of hypoxic-ischemic encephalopathy
- Metabolic disorder
- Other genetic disorders
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
Abnormal sleep wake cycles on AEEG
Time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit (NICU) which is on average about four weeks
6 secondary outcomes
Performance on neurologic screening tools
Time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Head ultrasound abnormalities
Time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Seizures
Time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Death
Time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Inability to feed orally
Time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Respiratory support requirement
Time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit which is on average about four weeks
Results and safety
The study was stopped early (reason given: due to inability to recruit sufficient sample size in reasonable time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Background: PubMed 18249516Massaro AN, El-Dib M, Glass P, Aly H. Factors associated with adverse neurodevelopmental outcomes in infants with congenital heart disease. Brain Dev. 2008 Aug;30(7):437-46. doi: 10.1016/j.braindev.2007.12.013. Epub 2008 Feb 4.
- Background: PubMed 16325677Brown MD, Wernovsky G, Mussatto KA, Berger S. Long-term and developmental outcomes of children with complex congenital heart disease. Clin Perinatol. 2005 Dec;32(4):1043-57, xi. doi: 10.1016/j.clp.2005.09.008.
- Background: PubMed 11060529Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.
- Background: PubMed 12563063Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
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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.
Ian Holzman, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Icahn School of Medicine at Mount Sinai 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 5 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: stopped early, as of the sponsor's last update on 19 Aug 2011. 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 was stopped early (reason given: due to inability to recruit sufficient sample size in reasonable time frame.). Results are not available in the source record.
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?
Abnormal sleep wake cycles on AEEG (time frame: from 24 hours of life to time of discharge home from the neonatal intensive care unit (NICU) which is on average about four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291797, which also lists 4 linked publications.
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 19 Aug 2011; AzTrials last refreshed its copy on 7 Nov 2026.