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Congenital Heart DiseaseNCT05670132

Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB)

A study testing Neurocardiac rehabilitation program in people with Congenital Heart Disease, run by University Hospital, Bordeaux at 6 sites in 3 countries.

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

Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae… Read more about this study

Who is it for?
Ages 8 to 25 years
Conditions the study is for
Congenital Heart Disease
What is being tested?
Neurocardiac rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
6 sitesin 3 countries
Study dates
3 Jun 2024to 3 Jun 2028
Phase
Interventional
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 8 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patient with a CHD of moderate to great complexity as defined in the 2019 AHA/ACC guidelines (Appendix 2)85.
  • History of cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life.
  • Age between 8 and 25 years at the time of enrolment.
  • Parental or legal guardian's consent for minors (<18 years) and personal consent for adults.
  • Social security affiliation (for France only)

Who cannot join

  • Unstable and/or severe heart failure: severe heart failure (class IV NYHA functional class), recent decompensated heart failure requiring hospitalisation and/or any significant change in medication (< 3 months before enrolment), systolic ventricle dysfunction (left ventricle or systemic ventricle ejection fraction < 50%)82.
  • Severe hypoxaemia: pulse oxygen saturation (SpO2) at rest <85%, and/or SpO2 at exercise <80%, and/or patient requiring oxygen therapy.
  • Pulmonary hypertension as defined by the 2020 ESC guidelines, whatever the aetiology83.
  • Significant systolic right ventricle (sRV) hypertension (sRV pressure > 50% of systemic systolic pressure).
  • Uncontrolled arrhythmia: symptomatic treated or untreated arrhythmia at rest and/or exercise, treated arrhythmia with sustained supraventricular or ventricular tachycardia on ECG monitoring or during exercise and/or CPET, occurrence or aggravation of any supraventricular or ventricular arrhythmia during exercise and/or CPET.
  • Advanced atrioventricular block (degree 2 or 3), occurrence or aggravation of any conduction disorder during exercise and/or CPET.
Show all 25Show fewer
  • Uncontrolled arterial hypertension at rest (e.g. if the blood pressure at rest during the consultation >140/90 mmHg in adults, >95th percentile in children84).
  • Acute or recent (< 3 months) myocarditis and pericarditis.
  • Symptomatic aortic or sub-aortic stenosis (mean gradient > 50 mmHg).
  • Non-corrected coarctation of the aorta (surgical or catheter-based repair) with a clinical systolic gradient > 20 mmHg.
  • Dilatation of the aorta (aortic root > 40 mm in adults, > 2 Z-score in children85 (http://www.parameterz.com/sites/aortic-root) except in the case of repaired congenital heart disease with dilatation of the aorta inherent in the malformation and without significant risk of aortic dissection (tetralogy of Fallot, pulmonary atresia with VSD, transposition of the great arteries, truncus arteriosus, double outlet right ventricle, or single ventricle).
  • Severe hypertrophic obstructive cardiomyopathy.
  • Acute systemic illness.
  • Recent (<3 months) intracardiac thrombus, embolism, or thrombophlebitis.
  • Inability to follow instructions and/or complete the questionnaires, as determined by the investigator.
  • Absolute contraindications for CPET: fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and patients with mental impairment leading to inability to cooperate.
  • Inability to undergo the physical intervention: inability to physically exercise, any invasive medical intervention occurring within 6 months preceding the enrolment or scheduled during the 12-month study period (such as cardiac surgery, catheter-based intervention, orthopaedic surgery, chemotherapy for cancer, or any other significant medical treatment or intervention, as determined by the investigator).
  • Patient with a previously diagnosed or suspected severe psychiatric disorder (major depression with or without suicidal ideation, psychotic diagnoses, severe anxiety /panic disorders) requiring hospitalization and/or continuous specialized care by a psychiatrist, as determined by the investigator.
  • Patients who benefited from a cardiac rehabilitation within the 12 months preceding the enrolment.
  • Patients who benefited from a computerized executive function or attention training such as Cogmed Working Memory Program within the 12 months preceding the enrolment.
  • For female patients: pregnancy, pregnancy plan, or breastfeeding woman following questioning of the patient.
  • Patients deprived of liberty due to an ongoing legal procedure, adult's patient under guardianship or curatorship or unable to personally express their consent.
  • Any other clinical and/or pharmacological treatment that is believed to interfere with the study or the optimal clinical care.
  • Initiation or total withdrawal of psychotropic medication (i.e., any psychotropic medication including methylphenidate, benzodiazepines, and mood stabilizers) within the 6 months preceding the enrolment.
  • Patient participating or wishing to participate in any interventional clinical research (drug trial, medical device, non-drug trial).

Trial locations and contacts

6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Pascal AMEDRO, MD,PhD contact

05 57 65 61 09 ext. +33

pascal.amedro@chu-bordeaux.fr

Johanna CALDERON, PhD contact

johanna.calderon@inserm.fr

6 sites in 3 countries

France4 sites, 4 recruiting

  • University Hospital of Montpellier - Arnaud de Villeneuve Hospital

    Montpellier, 34295

    Sophie GUILLAUMONT, MD, 04 67 33 81 12 ext. +33, s-guillaumont@chu-montpellier.fr

    Recruiting

  • Saint-Pierre Institute

    Palavas-les-Flots, 34250

    Sophie GUILLAUMONT, MD, 04 67 07 75 51 ext. +33, guillaumont.s@institut-saint-pierre.fr

    Recruiting

  • Hôpital Necker-Enfants malades (AP-HP)

    Paris, France, 75015

    Damien BONNET, MD,PhD, 01 44 49 43 44 ext. +33, damien.bonnet@aphp.fr

    Recruiting

  • University Hospital of Bordeaux - Haut-Levêque Hospital

    Pessac, 33604

    Marion AUDIE, MD, 05 57 65 64 65 ext. +33, marion.audie@chu-bordeaux.fr

    Recruiting

Other trials in France

Belgium1 site, 1 recruiting

  • Saint-Luc University Hospital

    Brussels

    Stéphane MONIOTTE, MD,PhD, 02 764 19 20 ext. +32, stephane.moniotte@uclouvain.be

    Recruiting

Other trials in Belgium

Germany1 site, 1 recruiting

  • Deutsches Herzzentrum München

    München, D-80636

    alfred HAGER, MD,PhD, 089-1218-1650 ext. +49, hager@dhm.mhn.de

    Not yet recruiting

Other trials in Germany

About this study

Official title: Impact of a Neuro-cardiac Rehabilitation Program on the Quality of Life of Children, Adolescents, and Young Adults With Congenital Heart Disease: the Multicentre Randomized Controlled QUALINEUROREHAB Trial

Remarkable progress in paediatric cardiology and surgery have led to the substantial increase of congenital heart disease (CHD) survivors. Long-term outcomes in rare and complex CHD have become a critical priority as three major sources of morbidity have been identified in this population: neurodevelopmental sequelae, mental health issues and reduced exercise capacity. These challenges adversely affect their quality of life and constitute a major public health issue. We seek to evaluate the efficacy of the first integrative and holistic program in Neuro-Cardiac Health associating physical and psychological rehabilitation for children with rare CHD compared to the standard of care. Children randomly assigned to the intervention will undergo a 12-week neuro-cardiac intervention including home-based adaptive physical exercise, telehealth parent and child psycho-education and child computerized cognitive training, as well in-person individual sessions of intervention reinforcement. Parents will be actively involved and will receive personalized feedback and educational resources. Children assigned to the control group will receive the standard of care in congenital cardiology. Post-intervention effects will be measured after 12-months on several outcomes including health-related quality of life (HRQoL), trained and untrained cognitive skills, mental health outcomes and cardiovascular/physical variables.

Read the detailed description

Neurodevelopmental and mental health issues and reduced exercise capacity are the most frequent long-term morbidities in youth with CHD. These problems worsen with age and play a critical role in reducing the quality of life of patients and their families. The QUALI-NEUROREHAB CHD multicentre, randomized controlled trial seeks to test the efficacy of an innovative home-based neuro-cardiac intervention to improve physical and mental health of children, adolescents and young adults with rare CHD, as assessed by the patients themselves using patient-reported outcomes and standardized assessments. Outcomes relate to changes in scores for health-related quality of life (HRQoL, primary outcome measure), neurodevelopmental and mental health outcomes, and cardiopulmonary exercise test parameters, 12 months post-enrolment, in patients with rare CHD aged 8 to 25 years old. This is a two-arm parallel design study: intervention versus control. Intervention using the neuro-cardiac rehabilitation program will be the active arm. Standard of care will be used for the control group and involves normal cardiology consultations and follow-up without intervention programs on physical activity or neurocognitive training. The intervention group will include 12 weeks of neuro-cardiac training, comprised of at-home adaptive physical exercise, telehealth consultations and computerized neurocognitive training as well in-person individual sessions of intervention reinforcement. We hypothesize an increase in the overall HRQoL score of 6 ± 14 points (over 100). With a 80% power, a bilateral alpha risk of 5%, and potentially 10% of loss to follow-up and/or missing data on the primary outcome, we need to randomize 96 patients to each group (N= 192, overall). Analysis will be performed using intent to treat (ITT) approach. We predict significant positive changes in quality of life, mental and physical health scores in patients who will be assigned to the neuro-cardiac intervention (active arm). If this intervention is effective, it can have critical public health implications for the organization and modalities of care for children with rare CHD in Europe. A neuro-cardiac rehabilitation programme tailored to the specific challenges of individuals with rare CHD would improve patient care pathways across major centers in Europe.

Being tested
Neurocardiac rehabilitation program, Standard of care
Keywords
Neuro-cardiac rehabilitation program, Quality of life
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.

  • Neurocardiac rehabilitation programOther

    Patients receiving a neurocardiac rehabilitation program for 12 weeks.

  • Standard of careOther

    No intervention during the neurocardiac rehabilitation program

Study groups in NCT05670132
Study groupRoleWhat they receive
Neurocardiac rehabilitation programExperimentalThe home-based neuro-cardiac rehabilitation program will consist of weekly sessions of neuro-cardiac training during 12 weeks at home. * The physical activity training consists of two 1-hour sessions of adapted physical activities per week supervised by an APA educator or equal. One weekly session is held in person, at home, and the second one in videoconference. All training sessions follow the same scheme with 30 minutes of bicycle training, adapted from high-intensity training (30-33), and 30 minutes of "free" adapted physical activities * The neuropsychological component will consist of 2 home-based weekly 25-minute sessions of computerized cognitive training via the new platform of CogMed (standard format) for the patient and 1 weekly 30/45-min teleconsultation session of neuropsychological feedback on every-day life emotional regulation and executive functioning applied to school and family life for either the parent (for ages 17 and younger) or young adults with CHD.
Receives: Other: Neurocardiac rehabilitation program
Standard of careActive comparatorThe control group will follow European recommendations for cardiology care (standard of care) without introducing any additional interventions for research purposes at the exception of primary (HRQoL questionnaires) and secondary outcomes
Receives: Other: Standard of care

What is being measured

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

  1. Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire

    Change in the self-reported total score of the PedsQL 4.0 questionnaire between baseline (Month 0) and the end of follow-up (Month 12) in both groups.

    Measured: between Month 0 and Month 12

Secondary outcomes (19)

  1. Proxy-reported total score of the Pediatric Quality of Life Inventory (PedsQL) for paediatric patients

    Measured: between Month 0 and Month 12

  2. Pediatric Quality of Life Inventory (PedsQL) 4.0 Health-related quality (HRQoL ) of life questionnaire score per dimension (self and proxy reports)

    Measured: between Month 0 and Month 12

  3. Behaviour Rating Inventory of Executive Function (BRIEF) scale scores

    BRIEF (8-18 years) and BRIEF-A (older than 18 years)

    These scales make it possible to identify executive dysfunctions that have an impact on daily life.

    BRIEF assesses behaviours based on questions grouped into 8 scales: inhibition, flexibility, emotional control, initiation, material organization, working memory, planning/organization, and control.

    For the BRIEF-A (18 years and +), 9 scales are available and those yield the same indices and general composite score.

    Measured: between Month 0 and Month 12

  4. Wisconsin Card Sorting Test scale score

    This test measures higher-order executive functioning including planning, anticipation, and cognitive flexibility.

    Measured: between Month 0 and Month 12

  5. Wechsler Intelligence Scale scores

    Scores on the main indices of the Wechsler Intelligence Scale (WISC-V for children, WAIS-IV for adults): verbal comprehension, visual-spatial abilities, working memory, fluid reasoning and processing speed.

    Measured: between Month 0 and Month 12

  6. NEPSY-II scale scores

    Score on tests of language (comprehension of instructions) and social cognition (understanding of facial emotions and theories of mind) from the NEPSY-II Child Neuropsychological Assessment battery

    Measured: between Month 0 and Month 12

  7. Wechsler Adult Memory Scale scores

    verbal and visual memory tests

    Measured: between Month 0 and Month 12

  8. Vineland questionnaire

    The Vineland-2 proxy-questionnaire of adaptive functioning: this is a parent- or other informant report on adaptive skills including social, communication, academic and daily-life independence of children.

    Measured: between Month 0 and Month 12

  9. Multiscore Depression Inventory for Children (MDI-C) scale score

    Scale providing access to the child's emotional world and more specifically to depression through 8 dimensions: self-esteem, anxiety, sad mood, social introversion, pessimism, defiance, low energy, and feelings of powerlessness.

    Measured: between Month 0 and Month 12

  10. Beck's Depression Inventory (BDI) scale score

    Self-report questionnaire (BDI-2) used to measure the characteristic attitudes and symptoms of depression

    Measured: between Month 0 and Month 12

  11. Revised Child Manifest Anxiety Scale (R-CMAS) score

    Self-administered questionnaire providing a more specific assessment of anxiety in its multiple expressions: worry/hypersensitivity, physiological anxiety, and social concern/concentration, based on a global measure of the child's or adolescent's anxiety level.

    Measured: between Month 0 and Month 12

  12. State-Trait Anxiety Inventory (STAI) - Form Y score

    Measured: between Month 0 and Month 12

  13. Resilience Scale score

    Resilience Scale for Children (RS10) score and Resilience Scale for Adults: self-administered questionnaire relating to the ability to cope and respond to life events.

    Measured: between Month 0 and Month 12

  14. Cardiopulmonary exercise test (CPET)

    Measured: between Month 0 and Month 12

  15. Muscular strength

    Muscular strength measured using a handgrip dynamometer . This parameter represents the strength of the upper extremities and correlates with inspiratory muscle function and Vital Capacity (FVC) of the lungs. It is measured three times on both hands while sitting with the elbows in a rectangular position. The highest value of the better arm will be used.

    Measured: between Month 0 and Month 12

  16. Metabolic equivalent of task (MET)

    Physical activity intensity and energy expenditure measured by an actimeter

    Measured: between Month 0 and Month 12

  17. Following physical activity questionnaires

    Self-administrated questionnaire : International Physical Activity Questionnaire(IPAQ) for patients ≥18 years

    Measured: between Month 0 and Month 12

  18. Following physical activity questionnaires

    Self-administrated questionnaire : Physical Activity Questionnaire for Children (PAQ-C) for 14 to 17-year-old children

    Measured: between Month 0 and Month 12

  19. Following physical activity questionnaires

    Self-administrated questionnaire : Physical Activity Questionnaire for Children (PAQ-A) for 8 to 14-year-old children

    Measured: between Month 0 and Month 12

Timeline

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

  1. First posted4 Jan 2023
  2. Study start3 Jun 2024
  3. Primary completion3 Jun 2028 (estimated)
  4. Study completion3 Jun 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05670132
Sponsor's protocol ID
CHUBX 2021/66
Status last verified
Jul 2026
First submitted
19 Dec 2022
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Access to participants' personal data will be subject to compliance with applicable laws and regulations, the information provided to participants, and the provisions on confidentiality and publication set out in the project's consortium agreement

Publications

  • Amedro P, Dorka R, Moniotte S, Guillaumont S, Fraisse A, Kreitmann B, Borm B, Bertet H, Barrea C, Ovaert C, Sluysmans T, De La Villeon G, Vincenti M, Voisin M, Auquier P, Picot MC. Quality of Life of Children with Congenital Heart Diseases: A Multicenter Controlled Cross-Sectional Study. Pediatr Cardiol. 2015 Dec;36(8):1588-601. doi: 10.1007/s00246-015-1201-x. Epub 2015 May 31.

    PubMed 26024647

  • Muller J, Christov F, Schreiber C, Hess J, Hager A. Exercise capacity, quality of life, and daily activity in the long-term follow-up of patients with univentricular heart and total cavopulmonary connection. Eur Heart J. 2009 Dec;30(23):2915-20. doi: 10.1093/eurheartj/ehp305. Epub 2009 Aug 18.

    PubMed 19692392

  • Amedro P, Picot MC, Moniotte S, Dorka R, Bertet H, Guillaumont S, Barrea C, Vincenti M, De La Villeon G, Bredy C, Soulatges C, Voisin M, Matecki S, Auquier P. Correlation between cardio-pulmonary exercise test variables and health-related quality of life among children with congenital heart diseases. Int J Cardiol. 2016 Jan 15;203:1052-60. doi: 10.1016/j.ijcard.2015.11.028. Epub 2015 Nov 10.

    PubMed 26638054

  • Amedro P, Gavotto A, Guillaumont S, Bertet H, Vincenti M, De La Villeon G, Bredy C, Acar P, Ovaert C, Picot MC, Matecki S. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018 Jun;104(12):1026-1036. doi: 10.1136/heartjnl-2017-312339. Epub 2017 Nov 23.

    PubMed 29170358

  • Muller J, Bohm B, Semsch S, Oberhoffer R, Hess J, Hager A. Currently, children with congenital heart disease are not limited in their submaximal exercise performance. Eur J Cardiothorac Surg. 2013 Jun;43(6):1096-100. doi: 10.1093/ejcts/ezs712. Epub 2013 Jan 22.

    PubMed 23345176

  • Calderon J, Bellinger DC, Hartigan C, Lord A, Stopp C, Wypij D, Newburger JW. Improving neurodevelopmental outcomes in children with congenital heart disease: protocol for a randomised controlled trial of working memory training. BMJ Open. 2019 Feb 19;9(2):e023304. doi: 10.1136/bmjopen-2018-023304.

    PubMed 30782877

  • Calderon J, Angeard N, Moutier S, Plumet MH, Jambaque I, Bonnet D. Impact of prenatal diagnosis on neurocognitive outcomes in children with transposition of the great arteries. J Pediatr. 2012 Jul;161(1):94-8.e1. doi: 10.1016/j.jpeds.2011.12.036. Epub 2012 Jan 28.

    PubMed 22284567

  • Calderon J, Stopp C, Wypij D, DeMaso DR, Rivkin M, Newburger JW, Bellinger DC. Early-Term Birth in Single-Ventricle Congenital Heart Disease After the Fontan Procedure: Neurodevelopmental and Psychiatric Outcomes. J Pediatr. 2016 Dec;179:96-103. doi: 10.1016/j.jpeds.2016.08.084. Epub 2016 Sep 28.

    PubMed 27692462

  • Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.

    PubMed 32860412

  • Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, Matecki S, Vandenberghe D, Ladeveze M, Bajolle F, Bosser G, Bouvaist H, Brosset P, Cohen L, Cohen S, Corone S, Dauphin C, Dulac Y, Hascoet S, Iriart X, Ladouceur M, Mace L, Neagu OA, Ovaert C, Picot MC, Poirette L, Sidney F, Soullier C, Thambo JB, Combes N, Bonnet D, Guillaumont S. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019 May 15;283:112-118. doi: 10.1016/j.ijcard.2018.12.050. Epub 2018 Dec 20.

    PubMed 30616811

  • Calderon J, Wypij D, Rofeberg V, Stopp C, Roseman A, Albers D, Newburger JW, Bellinger DC. Randomized Controlled Trial of Working Memory Intervention in Congenital Heart Disease. J Pediatr. 2020 Dec;227:191-198.e3. doi: 10.1016/j.jpeds.2020.08.038. Epub 2020 Aug 19.

    PubMed 32827526

  • Meyer M, Brudy L, Fuertes-Moure A, Hager A, Oberhoffer-Fritz R, Ewert P, Muller J. E-Health Exercise Intervention for Pediatric Patients with Congenital Heart Disease: A Randomized Controlled Trial. J Pediatr. 2021 Jun;233:163-168. doi: 10.1016/j.jpeds.2021.01.058. Epub 2021 Jan 29.

    PubMed 33516681

  • Abassi H, Gavotto A, Picot MC, Bertet H, Matecki S, Guillaumont S, Moniotte S, Auquier P, Moreau J, Amedro P. Impaired pulmonary function and its association with clinical outcomes, exercise capacity and quality of life in children with congenital heart disease. Int J Cardiol. 2019 Jun 15;285:86-92. doi: 10.1016/j.ijcard.2019.02.069. Epub 2019 Mar 1.

    PubMed 30857849

  • Morales Mestre N, Reychler G, Goubau C, Moniotte S. Correlation Between Cardiopulmonary Exercise Test, Spirometry, and Congenital Heart Disease Severity in Pediatric Population. Pediatr Cardiol. 2019 Apr;40(4):871-877. doi: 10.1007/s00246-019-02084-5. Epub 2019 Mar 8.

    PubMed 30850878

  • Hager A, Hess J. Comparison of health related quality of life with cardiopulmonary exercise testing in adolescents and adults with congenital heart disease. Heart. 2005 Apr;91(4):517-20. doi: 10.1136/hrt.2003.032722.

    PubMed 15772218

Questions about this trial

What is this clinical trial studying?

A study testing Neurocardiac rehabilitation program in people with Congenital Heart Disease, run by University Hospital, Bordeaux at 6 sites in 3 countries.

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 5 inclusion and 25 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, Belgium, Germany. 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 Pascal AMEDRO, MD,PhD (05 57 65 61 09 ext. +33, pascal.amedro@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total score of the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire (time frame: between Month 0 and Month 12). 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 NCT05670132, which also lists 27 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 8 Jul 2026.

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