Complex Congenital Heart DefectNCT03104751
Neurodevelopment in Infants With Complex Congenital Heart Defects
An observational study of Complex Congenital Heart Defect, run by Ohio State University at 1 site in United States.
Trial summary
The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD). Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Complex Congenital Heart Defect
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 24 Oct 2018
- 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 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants are infants born with a complex congenital heart defect.Cardiac defects include, but are not be limited to: atrioventricular canal defect, double outlet right ventricle, hypoplastic left heart syndrome, interrupted aortic arch, pulmonary atresia, tetralogy of Fallot, and transposition of the great arteries.All participants are recruited from Nationwide Children's Hospital in Columbus, OH. Healthy infants will also be enrolled as a comparison group.
Who may be able to join
- at least 36 weeks gestational age
- diagnosed with a Complex Congenital Heart Defect
- have at least one English-speaking adult family member
Who cannot join
- presence of co-existing, non-cardiac congenital anomalies
- ongoing post-operative cardiac pacing
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).
Read the detailed description
The investigators' long-term goals are to develop a method of identifying infants likely to have adverse neurodevelopmental outcomes following neonatal treatment for CCHD and to develop and test interventions that can be applied early in infancy. The necessary first step is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with CCHD. Each measure provides unique information about development and will include (1) neuroimaging for brain maturity and brain injury, (2) hair and fingernails for cortisol and saliva for immune system function, (3) heart rate variability (HRV) for autonomic nervous system function (ANS), (4) Bayley Scales of Infant Development (BSID-III) for cognitive and motor function, (5) a naturalistic play session incorporating kicking, general movement analysis, or the Test of Infant Motor Performance (TIMP) for motor development, and (6) the mobile paradigm for learning, memory, and task-specific coordination. The investigators will look at types of relationships among these measures within each time point for description of development and across each time point for prediction of development. The investigators' core hypotheses are that infants with CCHD will have measurable deficits in cognitive and motor development birth to ~ 6 months of age when compared with a healthy control group and that a typology developed from neurodevelopmental measures will reliably predict cognitive and motor delay in the first six months of life in infants with CCHD.
- Conditions
- Complex Congenital Heart Defect
- Keywords
- Complex Congenital Heart Defect, Infants
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 |
|---|---|---|
| Infants with Complex Congenital Heart Defect | Infants diagnosed a Complex Congenital Heart Defect | |
| Comparison/Healthy Infants | Infants born without genetic syndromes or cardiac condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MRI (Magnetic Resonance Imaging) of brain - infants with CCHD only
Brain MRI
Measured: 1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age
Change in Test of Infant Motor Performance (TIMP)
test of early motor development
Measured: 0-30 days, 3 months
Change in Mobile Paradigm
Measure of learning, memory, and task-specific kicking coordination in infants
Measured: 3 months and 6 months
Change in Heart Rate Variability
Measure of autonomic nervous system function and development
Measured: 30 days, 3 months, 6 months
Secondary outcomes (4)
Bayley Scales of Motor Development
The Bayley Scales of Infant and Toddler Development is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.
Measured: 3 months, 6 months
Edinburgh Postnatal Depression Scale
self report survey to assess maternal depression
Measured: 0-30 days, 3 months, 6 months
Infant-Toddler Quality of Life Questionnaire
self report survey to assess infant health status and physical and psychosocial functioning
Measured: 0-30 days, 3 months, 6 months
State-Trait Anxiety Inventory
sefl report survey measure of anxiety
Measured: 0-30 days, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start30 Jun 2016
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex Congenital Heart DefectStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Nationwide Children's Hospital
- Responsible party
- Principal investigator, Jill Heathcock, Ohio State University
- Investigators
- Jill Heathcock, MPT, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104751
- Sponsor's protocol ID
- 2015N0040
- Status last verified
- Feb 2021
- First submitted
- 27 Mar 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tripathi T, Harrison TM, Simsic JM, Cabral TI, Heathcock JC. Screening and Evaluation of Neurodevelopmental Impairments in Infants Under 6 Months of Age with Congenital Heart Disease. Pediatr Cardiol. 2022 Mar;43(3):489-496. doi: 10.1007/s00246-021-02745-4. Epub 2022 Feb 21.
PubMed 35190880
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopment in Infants With Complex Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT03104751
- Acronym / sponsor ID
- 2015N0040
- Conditions
- Complex Congenital Heart Defect
- Keywords
- Complex Congenital Heart Defect, Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, Nationwide Children's Hospital
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- 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.
The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).
Detailed description
The investigators' long-term goals are to develop a method of identifying infants likely to have adverse neurodevelopmental outcomes following neonatal treatment for CCHD and to develop and test interventions that can be applied early in infancy. The necessary first step is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with CCHD. Each measure provides unique information about development and will include (1) neuroimaging for brain maturity and brain injury, (2) hair and fingernails for cortisol and saliva for immune system function, (3) heart rate variability (HRV) for autonomic nervous system function (ANS), (4) Bayley Scales of Infant Development (BSID-III) for cognitive and motor function, (5) a naturalistic play session incorporating kicking, general movement analysis, or the Test of Infant Motor Performance (TIMP) for motor development, and (6) the mobile paradigm for learning, memory, and task-specific coordination. The investigators will look at types of relationships among these measures within each time point for description of development and across each time point for prediction of development. The investigators' core hypotheses are that infants with CCHD will have measurable deficits in cognitive and motor development birth to ~ 6 months of age when compared with a healthy control group and that a typology developed from neurodevelopmental measures will reliably predict cognitive and motor delay in the first six months of life in infants with CCHD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with Complex Congenital Heart Defect | – | –Infants diagnosed a Complex Congenital Heart Defect |
| Comparison/Healthy Infants | – | –Infants born without genetic syndromes or cardiac condition. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants are infants born with a complex congenital heart defect.Cardiac defects include, but are not be limited to: atrioventricular canal defect, double outlet right ventricle, hypoplastic left heart syndrome, interrupted aortic arch, pulmonary atresia, tetralogy of Fallot, and transposition of the great arteries.All participants are recruited from Nationwide Children's Hospital in Columbus, OH. Healthy infants will also be enrolled as a comparison group.
Key inclusion criteria (3 listed)
- at least 36 weeks gestational age
- diagnosed with a Complex Congenital Heart Defect
- have at least one English-speaking adult family member
Key exclusion criteria (2 listed)
- presence of co-existing, non-cardiac congenital anomalies
- ongoing post-operative cardiac pacing
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
Change in MRI (Magnetic Resonance Imaging) of brain - infants with CCHD only
Time frame: 1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age
Brain MRI
Change in Test of Infant Motor Performance (TIMP)
Time frame: 0-30 days, 3 months
test of early motor development
Change in Mobile Paradigm
Time frame: 3 months and 6 months
Measure of learning, memory, and task-specific kicking coordination in infants
Change in Heart Rate Variability
Time frame: 30 days, 3 months, 6 months
Measure of autonomic nervous system function and development
4 secondary outcomes
Bayley Scales of Motor Development
Time frame: 3 months, 6 months
Edinburgh Postnatal Depression Scale
Time frame: 0-30 days, 3 months, 6 months
Infant-Toddler Quality of Life Questionnaire
Time frame: 0-30 days, 3 months, 6 months
State-Trait Anxiety Inventory
Time frame: 0-30 days, 3 months, 6 months
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 24 Feb 2021.
- Derived from this study: PubMed 35190880Tripathi T, Harrison TM, Simsic JM, Cabral TI, Heathcock JC. Screening and Evaluation of Neurodevelopmental Impairments in Infants Under 6 Months of Age with Congenital Heart Disease. Pediatr Cardiol. 2022 Mar;43(3):489-496. doi: 10.1007/s00246-021-02745-4. Epub 2022 Feb 21.
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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.
Jill Heathcock, MPT, PhD principal investigator
Ohio State University
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 Complex Congenital Heart Defect, run by Ohio State 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 24 Feb 2021. 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?
Change in MRI (Magnetic Resonance Imaging) of brain - infants with CCHD only (time frame: 1 to 5 days days prior to surgery, 4-10 days after surgery, 6 months of age). The study lists 4 primary outcomes in all. 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 NCT03104751, which also lists 1 linked publication.
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 24 Feb 2021.