Congenital Heart Disease in ChildrenNEMOCARDNCT04295239
Non-invasive Monitoring of Cerebral Autoregulation in Perioperative Neonatal Cardiac Surgery
A study testing MRI in people with Congenital Heart Disease in Children and Extracorporeal Circulation; Complications, run by Nantes University Hospital at 1 site in France.
Trial summary
Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Congenital Heart Disease in Children, Extracorporeal Circulation; Complications
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2020to 19 Feb 2022
- Phase
- Interventional
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any newborn (0-28 days) with congenital heart disease, hospitalized in the preoperative period at the Nantes University Hospital, for whom a decision is made to perform an operation under extracorporeal circulation, suitable to be transported for an MRI without risk, advice taken from the treating team.
Who cannot join
- emergency cardiac surgery
- Preoperative extracorporeal assistance
- Preoperative intubation
- Preoperative administration of inotropes
- Pre-operative instability contra-indicating pre-operative MRI
- Dependence on a pace maker contra-indicating MRI Imaging.
- Parental consent refusal
- Non-affiliation to a health security insurance
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. The quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The association between time spent outside the limits of cerebral autoregulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain autoregulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. The main objective of the research is to determine the association between time spent outside individually determined cerebral autoregulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside autoregulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Pre and Post operative MRI
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Pre-operative AND post-operative MRI Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.
duration of period outside cerebral autoregulation limits, Number, size and extent of new lesions on post-operative MRI.
Patients will be classified into 2 categories according to whether or not there are new lesions on MRI.
The lesions retained will be infarcts, white matter lesions and intraparenchymal hemorrhages, classified according to the Magnetic Resonance Imaging Abnormality Scoring System.
Measured: 6 weeks after cardiac surgery
Secondary outcomes (7)
describe association between time spent outside autoregulation limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.
duration of period outside cerebral autoregulation limits, Standardized clinical examination according to Amiel Tison at hospital discharge.
Measured: 6 weeks after cardiac surgery
describe predictive factors of postoperative encephalopathy
duration of extra-corporal circulation,
Measured: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of aortic clamp
Measured: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of selective cerebral perfusion,
Measured: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of hypothermia deepness
Measured: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of critical NIRS
Measured: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
duration of critical median arterial pression (PAM)
Measured: day 1 (cardiac surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start10 Mar 2020
- Primary completion19 Feb 2022
- Study completion19 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, prospective and pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295239
- Sponsor's protocol ID
- RC19_0413
- Acronym
- NEMOCARD
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2020
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Monitoring of Cerebral Autoregulation in Perioperative Neonatal Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04295239
- Acronym / sponsor ID
- NEMOCARD / RC19_0413
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 4 Mar 2020 (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.
Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. The quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The association between time spent outside the limits of cerebral autoregulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain autoregulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. The main objective of the research is to determine the association between time spent outside individually determined cerebral autoregulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside autoregulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, prospective and pilot study
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Procedure: MRIPre-operative AND post-operative MRI |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any newborn (0-28 days) with congenital heart disease, hospitalized in the preoperative period at the Nantes University Hospital, for whom a decision is made to perform an operation under extracorporeal circulation, suitable to be transported for an MRI without risk, advice taken from the treating team.
Key exclusion criteria (8 listed)
- emergency cardiac surgery
- Preoperative extracorporeal assistance
- Preoperative intubation
- Preoperative administration of inotropes
- Pre-operative instability contra-indicating pre-operative MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPre and Post operative MRI | Procedure or surgery | MRI |
Primary outcome
determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output.
Time frame: 6 weeks after cardiac surgery
duration of period outside cerebral autoregulation limits, Number, size and extent of new lesions on post-operative MRI. Patients will be classified into 2 categories according to whether or not there are new lesions on MRI. The lesions retained will be infarcts, white matter lesions and intraparenchymal hemorrhages, classified according to the Magnetic Resonance Imaging Abnormality Scoring System.
7 secondary outcomes
describe association between time spent outside autoregulation limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria.
Time frame: 6 weeks after cardiac surgery
describe predictive factors of postoperative encephalopathy
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
Time frame: day 1 (cardiac surgery)
describe predictive factors of postoperative encephalopathy
Time frame: day 1 (cardiac surgery)
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 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Congenital Heart Disease in Children and Extracorporeal Circulation; Complications, run by Nantes University Hospital at 1 site in France.
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 1 inclusion and 8 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 29 Jul 2024. 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 France. 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?
determine the association between time spent outside individually determined cerebral autoregulation limits and the development of brain lesions suggestive of low brain output. (time frame: 6 weeks after cardiac surgery). 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 29 Jul 2024.