AzTrials
AzTrials

Neurodevelopmental DisordersKHBNCT05658965

KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders

An observational study of Neurodevelopmental Disorders and Congenital Cardiomyopathy, run by University Hospital, Lille at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention… Read more about this study

Who is it for?
Ages 1 day to 1 year
How many people
50 participants
Where
1 siteFrance
Study dates
10 Oct 2022to 13 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 1 year
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children of less than 1 year suffering of congenital cardiopathy admitted for cardiac surgery on extracorporal circulation on the CHU of Lille.

Who may be able to join

  • Child of less than 1 year admitted for cardiac surgery on extracorporal circulation on the CHU of Lille during the study period.
  • Child with congenital cardiopathy with necessity to be operated before 1 year old.

Who cannot join

  • Child with no necessity of surgery before 1 year old.
  • Medical history of cardiac surgery.
  • Refusal of consent by the parents.
  • No social security.
  • Child not operated on the CHU of LILLE.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sylvie NGUYEN THE TICH, MD,PhD contact

0320445962 ext. +33

sylvie.nguyenthetich@chu-lille.fr

Sylvie JORIOT, MD contact

0320445962 ext. +33

sylvie.joriot@chu-lille.fr

France1 site, 1 recruiting

  • CHU de LILLE

    Lille, Hauts-de-France, 59037

    Sylvie NGUYEN THE TICH, MD, PhD, 320445962 ext. +33, sylvie.nguyenthetich@chu-lille.fr

    Sylvie JORIOT, MD, 0320445962 ext. +33, sylvie.joriot@chu-lille.fr

    Recruiting

Other trials in France

About this study

Official title: Intérêt de l'électroencéphalogramme précoce en Chirurgie de Cardiopathie congénitale Pour prédire la Survenue de Troubles du neurodéveloppement

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.

The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.

On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Read the detailed description

Interest of early EEG on congenital cardiopathy surgery to predict the neurodevelopmental disorders occurence.

Congenital cardiopathy are frequent malformations (1/100 birth). The progress of surgery permit a survival rate at the adult age of more than 90%. The long terms consequences must be taken in account and the nerodevelopmental disorders are in first place (intelectual deficiency, autism spectrum disorders, or attention disorders) and presents in 30 to 60% of the patients (Calmant, 2015). The impact can be important on the scolarity, the studies, the professional activity and finaly on the quality of life of the patients becomming adults.

The identification of the risk factors on surgery period should permit to propose the most adapted follow-up to the specifics needs of each patients.

On the scientific plans, the identification of early markers on brain dammage on EEG should permit to better apprehend the physiopathologic mecanisms involved.

Keywords
EEG, Neurodevelopmental Disorders, Congenital Cardiomyopathy, Orality Disorders
Medical subject headings
Neurodevelopmental Disorders, Cardiomyopathy, infantile histiocytoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interest of pre and post surgery EEG on neurodevelopmental disorders

    Evaluation of the interest of pre and post surgery EEG in the prediction of neurodevelopmental disorders on patients operated of congenital cardiopathy before the age of 1 year old.

    Measured: Age of patient : 24 Months

Secondary outcomes (2)

  1. Association between orality disorders and neurodevelopmental disorders

    Association between the presence of pre surgery and 1 year old orality disorder and occurence of neurodevelopmental disorders.

    Measured: Age of patient : 24 Months

  2. Interest of post surgery EEG neurodevelopmental disorders at 24 months old

    Evaluation of the interest of 24 months old post surgery EEG in the prediction of neurodevelopmental disorders on patients operated of congenital cardiopathy before the age of 1 year old, having a normal pre surgery EEG.

    Measured: Age of patient : 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start10 Oct 2022
  3. Primary completion13 Oct 2026 (estimated)
  4. Study completion13 Oct 2026 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658965
Sponsor's protocol ID
2021_0160
Other IDs
2022-A00335-38
Acronym
KHB
Status last verified
Apr 2026
First submitted
12 Dec 2022
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, Mussatto KA, Uzark K, Goldberg CS, Johnson WH Jr, Li J, Smith SE, Bellinger DC, Mahle WT; American Heart Association Congenital Heart Defects Committee, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Stroke Council. Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012 Aug 28;126(9):1143-72. doi: 10.1161/CIR.0b013e318265ee8a. Epub 2012 Jul 30.

    PubMed 22851541

  • Calderon J, Willaime M, Lelong N, Bonnet D, Houyel L, Ballon M, Goffinet F, Khoshnood B; EPICARD study group. Population-based study of cognitive outcomes in congenital heart defects. Arch Dis Child. 2018 Jan;103(1):49-56. doi: 10.1136/archdischild-2016-310830. Epub 2017 Aug 5.

    PubMed 28780508

  • Ryan KR, Jones MB, Allen KY, Marino BS, Casey F, Wernovsky G, Lisanti AJ. Neurodevelopmental Outcomes Among Children With Congenital Heart Disease: At-Risk Populations and Modifiable Risk Factors. World J Pediatr Congenit Heart Surg. 2019 Nov;10(6):750-758. doi: 10.1177/2150135119878702. Epub 2019 Oct 28.

    PubMed 31658880

  • Jayaram N, Spertus JA, Kennedy KF, Vincent R, Martin GR, Curtis JP, Nykanen D, Moore PM, Bergersen L. Modeling Major Adverse Outcomes of Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Catheterization: Observations From the NCDR IMPACT Registry (National Cardiovascular Data Registry Improving Pediatric and Adult Congenital Treatment). Circulation. 2017 Nov 21;136(21):2009-2019. doi: 10.1161/CIRCULATIONAHA.117.027714. Epub 2017 Sep 7.

    PubMed 28882885

  • Mulkey SB, Yap VL, Bai S, Ramakrishnaiah RH, Glasier CM, Bornemeier RA, Schmitz ML, Bhutta AT. Amplitude-integrated EEG in newborns with critical congenital heart disease predicts preoperative brain magnetic resonance imaging findings. Pediatr Neurol. 2015 Jun;52(6):599-605. doi: 10.1016/j.pediatrneurol.2015.02.026. Epub 2015 Mar 5.

    PubMed 25838043

  • Mebius MJ, Kooi EMW, Bilardo CM, Bos AF. Brain Injury and Neurodevelopmental Outcome in Congenital Heart Disease: A Systematic Review. Pediatrics. 2017 Jul;140(1):e20164055. doi: 10.1542/peds.2016-4055. Epub 2017 Jun 13.

    PubMed 28607205

  • Asakai H, Cardamone M, Hutchinson D, Stojanovski B, Galati JC, Cheung MM, Mackay MT. Arterial ischemic stroke in children with cardiac disease. Neurology. 2015 Dec 8;85(23):2053-9. doi: 10.1212/WNL.0000000000002036. Epub 2015 Sep 25.

    PubMed 26408496

  • Latal B, Wohlrab G, Brotschi B, Beck I, Knirsch W, Bernet V. Postoperative Amplitude-Integrated Electroencephalography Predicts Four-Year Neurodevelopmental Outcome in Children with Complex Congenital Heart Disease. J Pediatr. 2016 Nov;178:55-60.e1. doi: 10.1016/j.jpeds.2016.06.050. Epub 2016 Jul 22.

    PubMed 27453368

  • Meyer S, Poryo M, Shatat M, Gortner L, Abdul-Khaliq H. The role of EEG recordings in children undergoing cardiac surgery for congenital heart disease. Wien Med Wochenschr. 2017 Sep;167(11-12):251-255. doi: 10.1007/s10354-017-0576-0. Epub 2017 Jun 28.

    PubMed 28660303

  • Shellhaas RA, Chang T, Tsuchida T, Scher MS, Riviello JJ, Abend NS, Nguyen S, Wusthoff CJ, Clancy RR. The American Clinical Neurophysiology Society's Guideline on Continuous Electroencephalography Monitoring in Neonates. J Clin Neurophysiol. 2011 Dec;28(6):611-7. doi: 10.1097/WNP.0b013e31823e96d7. No abstract available.

    PubMed 22146359

  • Gutierrez-Colina AM, Topjian AA, Dlugos DJ, Abend NS. Electroencephalogram monitoring in critically ill children: indications and strategies. Pediatr Neurol. 2012 Mar;46(3):158-61. doi: 10.1016/j.pediatrneurol.2011.12.009.

    PubMed 22353290

  • Peyvandi S, Chau V, Guo T, Xu D, Glass HC, Synnes A, Poskitt K, Barkovich AJ, Miller SP, McQuillen PS. Neonatal Brain Injury and Timing of Neurodevelopmental Assessment in Patients With Congenital Heart Disease. J Am Coll Cardiol. 2018 May 8;71(18):1986-1996. doi: 10.1016/j.jacc.2018.02.068.

    PubMed 29724352

  • Meuwly E, Feldmann M, Knirsch W, von Rhein M, Payette K, Dave H, Tuura ROG, Kottke R, Hagmann C, Latal B, Jakab A; Research Group Heart and Brain*. Postoperative brain volumes are associated with one-year neurodevelopmental outcome in children with severe congenital heart disease. Sci Rep. 2019 Jul 26;9(1):10885. doi: 10.1038/s41598-019-47328-9.

    PubMed 31350426

  • Claessens NHP, Khalili N, Isgum I, Ter Heide H, Steenhuis TJ, Turk E, Jansen NJG, de Vries LS, Breur JMPJ, de Heus R, Benders MJNL. Brain and CSF Volumes in Fetuses and Neonates with Antenatal Diagnosis of Critical Congenital Heart Disease: A Longitudinal MRI Study. AJNR Am J Neuroradiol. 2019 May;40(5):885-891. doi: 10.3174/ajnr.A6021. Epub 2019 Mar 28.

    PubMed 30923087

  • Long SH, Harris SR, Eldridge BJ, Galea MP. Gross motor development is delayed following early cardiac surgery. Cardiol Young. 2012 Oct;22(5):574-82. doi: 10.1017/S1047951112000121. Epub 2012 Feb 29.

    PubMed 22373640

Questions about this trial

What is this clinical trial studying?

An observational study of Neurodevelopmental Disorders and Congenital Cardiomyopathy, run by University Hospital, Lille 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 2 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sylvie NGUYEN THE TICH, MD,PhD (0320445962 ext. +33, sylvie.nguyenthetich@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interest of pre and post surgery EEG on neurodevelopmental disorders (time frame: Age of patient : 24 Months). 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 NCT05658965, which also lists 23 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 24 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in