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RecruitingNCT05658965KHBUpdated Apr 24, 2026

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

An observational study in Neurodevelopmental Disorders and Congenital Cardiomyopathy, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 1 Day to 1 Year. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
1 Day to 1 Year
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 50 studies in Neurodevelopmental Disorders with a site in France — 31 open to participants now, 33 under way, 5 of them phase 3. Neurodevelopmental Disorders · France.

Planned enrollment
21st of 25
50 · median 200
Started
2022
with 7 others
Observational
25 of 50
13 open now
Primary completion
2026-10
later than 5 of 32 live
Registered
18th of 50
by date
Lead sponsor
3 of 50
University Hospital, Lille

Among the 50 studies in Neurodevelopmental Disorders with a site in France, this one is the 21st largest by planned enrollment of the 25 observational ones, is one of 8 that started in 2022, is one of 25 observational ones, reaches primary completion later than 5 of the 32 other live ones, and was the 18th registered.

By phase

50 studies; the count open now beside each. This study's row is marked.

Observationalthis study25 · 13 open
No phase17 · 13 open
Phase 35 · 3 open
Phase 22 · 2 open
Phase 41 · 0 open

By the year they started

First in 2006; this study’s year is marked. 8 started in 2022.

Size and results

Median enrollment 132 across the 25 interventional studies, 200 across the 25 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 50 studies in Neurodevelopmental Disorders with a site in France, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Neurodevelopmental Disorders
  • Congenital Cardiomyopathy

Keywords

  • EEG
  • Neurodevelopmental Disorders
  • Congenital Cardiomyopathy
  • Orality Disorders
04

Who can participate

Ages eligible
1 Day to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: Age of patient : 24 Months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: Age of patient : 24 Months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
  • Flamant C, Branger B, Nguyen The Tich S, de la Rochebrochard E, Savagner C, Berlie I, Roze JC. Parent-completed developmental screening in premature children: a valid tool for follow-up programs. PLoS One. 2011;6(5):e20004. doi: 10.1371/journal.pone.0020004. Epub 2011 May 26. PubMed 21637833 ↗
  • Ribera I, Ruiz A, Sanchez O, Eixarch E, Antolin E, Gomez-Montes E, Perez-Cruz M, Cruz-Lemini M, Sanz-Cortes M, Arevalo S, Ferrer Q, Vazquez E, Vega L, Dolader P, Montoliu A, Boix H, Simoes RV, Masoller N, Sanchez-de-Toledo J, Comas M, Bartha JM, Galindo A, Martinez JM, Gomez-Roig L, Crispi F, Gomez O, Carreras E, Cabero L, Gratacos E, Llurba E. Multicenter prospective clinical study to evaluate children short-term neurodevelopmental outcome in congenital heart disease (children NEURO-HEART): study protocol. BMC Pediatr. 2019 Sep 10;19(1):326. doi: 10.1186/s12887-019-1689-y. PubMed 31506079 ↗
  • Hirsch LJ, Fong MWK, Leitinger M, LaRoche SM, Beniczky S, Abend NS, Lee JW, Wusthoff CJ, Hahn CD, Westover MB, Gerard EE, Herman ST, Haider HA, Osman G, Rodriguez-Ruiz A, Maciel CB, Gilmore EJ, Fernandez A, Rosenthal ES, Claassen J, Husain AM, Yoo JY, So EL, Kaplan PW, Nuwer MR, van Putten M, Sutter R, Drislane FW, Trinka E, Gaspard N. American Clinical Neurophysiology Society's Standardized Critical Care EEG Terminology: 2021 Version. J Clin Neurophysiol. 2021 Jan 1;38(1):1-29. doi: 10.1097/WNP.0000000000000806. No abstract available. PubMed 33475321 ↗
  • Murray DM, Boylan GB, Ryan CA, Connolly S. Early EEG findings in hypoxic-ischemic encephalopathy predict outcomes at 2 years. Pediatrics. 2009 Sep;124(3):e459-67. doi: 10.1542/peds.2008-2190. Epub 2009 Aug 24. PubMed 19706569 ↗
  • Barkovich AJ, Hajnal BL, Vigneron D, Sola A, Partridge JC, Allen F, Ferriero DM. Prediction of neuromotor outcome in perinatal asphyxia: evaluation of MR scoring systems. AJNR Am J Neuroradiol. 1998 Jan;19(1):143-9. PubMed 9432172 ↗
  • Agarwal S, Sud K, Menon V. Nationwide Hospitalization Trends in Adult Congenital Heart Disease Across 2003-2012. J Am Heart Assoc. 2016 Jan 19;5(1):e002330. doi: 10.1161/JAHA.115.002330. PubMed 26786543 ↗
  • Lacour-Gayet F, Clarke D, Jacobs J, Gaynor W, Hamilton L, Jacobs M, Maruszewski B, Pozzi M, Spray T, Tchervenkov C, Mavroudis C; Aristotle Committee. The Aristotle score for congenital heart surgery. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2004;7:185-91. doi: 10.1053/j.pcsu.2004.02.011. PubMed 15283368 ↗
  • Budts W, Borjesson M, Chessa M, van Buuren F, Trigo Trindade P, Corrado D, Heidbuchel H, Webb G, Holm J, Papadakis M. Physical activity in adolescents and adults with congenital heart defects: individualized exercise prescription. Eur Heart J. 2013 Dec;34(47):3669-74. doi: 10.1093/eurheartj/eht433. Epub 2013 Nov 7. No abstract available. PubMed 24204010 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Oct 2026, 48 months after the start.

Of 67 non-industry observational studies under Neurodevelopmental Disorders, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's planned 48 months is below that.

Counting every sponsor, half of 70 studies reached it within 59 months; a quarter within 32 and three quarters within 101.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2022
First posted
Dec 21, 2022
StartActual
Oct 10, 2022
Primary completionEst.
Oct 13, 2026
CompletionEst.
Oct 13, 2026
Last update
Apr 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05658965
Responsible party
Sponsor
First posted
Dec 21, 2022
Start date
Oct 10, 2022
Primary completion
Oct 13, 2026 (estimated)
Completion
Oct 13, 2026 (estimated)
Last update
Apr 24, 2026

Study contacts

Sylvie NGUYEN THE TICH, MD,PhD
Contact
sylvie.nguyenthetich@chu-lille.fr
0320445962 ext. +33
Sylvie JORIOT, MD
Contact
sylvie.joriot@chu-lille.fr
0320445962 ext. +33
Flavien GAUTRON, CRA
study chair · CHU de Lille
Gaëlle GUYOT, CRA
study chair · CHU de Lille

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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