Complex Congenital Heart DiseaseEt APRéS CaNCT06884046
Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
A study testing Personalized support project in people with Complex Congenital Heart Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Half of children with congenital heart disease develop specific neurodevelopmental disorders. Neurodevelopmental disorders are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Complex Congenital Heart Disease
- What is being tested?
- Personalized support project
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2025to 6 Feb 2027
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents whose fetus has congenital heart disease diagnosed in antenatal, which will be operated in the neonatal period (between 0 and 28 days of life) within our sector.
- Parents followed in the congenital heart disease sector of the University Hospital of Bordeaux as soon as the diagnosis is announced in antenatal.
- Free, informed and signed written consent of the couple or single mother in a single parent setting or by a third person (in case of physical disability of the participant) and the investigator (no later than the day of inclusion and before any examination required by the research).
- Person affiliated or beneficiary of a social security scheme (excluding AME).
- Parents with parental authority.
Who cannot join
- Parents who do not understand or read French and cannot be accompanied by a third party for translation.
- Parents with major psychiatric disorders.
- Parents deprived of liberty due to ongoing legal proceedings.
- Parents under guardianship or curatorship or unable to personally express consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologique Haut-Lévêque
Pessac, France, 33604
Laurie PONTEINS, +33 05 57 65 67 93 ext. +33, laurie.ponteins@chu-bordeaux.fr
About this study
Official title: Evaluation of the Feasibility of Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
Half of children with congenital heart disease develop specific neurodevelopmental disorders. Neurodevelopmental disorders are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. The stress perceived by parents of children with congenital heart disease varies depending on the time of diagnosis, the organization of care inherent in neonatal management and the type of pathology diagnosed.
The main objective is to evaluate the feasibility of a multidisciplinary and personalised model of support for parental stress, from the ante-natal period, in the context of their child's neonatal cardiac surgery.
Read the detailed description
Congenital heart disease (CC) is the most common congenital malformation. Every year, 8 newborns out of 1000 are affected by these pathologies worldwide and about 20% of them will require intervention in the first days of life. The complexity of heart disease, factors intrinsic to the patient as well as surgical techniques can be the cause of neurological abnormalities. Indeed, 43% of these CC newborns are already carriers of a cerebral anomaly in the perinatal period.
Neurodevelopmental disorders (NDD) are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. The stress perceived by parents of children with CC varies depending on the time of diagnosis, the type of pathology and the organization of neonatal care.
It is essential to accompany these parents with personalized care. It must be comprehensive, multidisciplinary and empathetic, with the aim of improving the neurodevelopmental prognosis of these children, and family well-being.
Through this project of accompaniment proposed from the antenatal, we innovate by integrating consultations by the paramedical team of the resuscitation, the implementation of a personalized support project that meets the expectations and needs of families for better care of their child. A parental stress assessment will be carried out at 4 times of the family care journey.
- Conditions
- Complex Congenital Heart Disease
- Being tested
- Personalized support project
- Keywords
- Neurodevelopment, Stress parental, Parental guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized support projectOther
- Presence of a child nurse at the consultation of the anesthesiologist-resuscitator.
- Antenatal paramedical consultation conducted by a child nurse composed of a semi-structured interview and an evaluation of Parental Stress by the ISP-4 self-questionnaire.
- Implementation of the personalized support project
- Self-assessment of parental stress using the ISP-4 self-questionnaire (child admitted to intensive care or resuscitation unit)
- Application of the personalised support project
- Self-assessment of parental stress using the ISP-4 self-questionnaire (child discharged from intensive care)
- Paramedical follow-up consultation with parents (semi-directive interview, ISP-4 self-questionnaire) and assessment of the child's psychomotor development in the child's 6th month of life
| Study group | Role | What they receive |
|---|---|---|
| Accompaniment project | Experimental | The experimental intervention envisaged combines specific monitoring and the implementation of a personalised support programme. Receives: Other: Personalized support project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Families participation evaluation
The participation of families in the proposed accompaniment will be evaluated by the participation rate: number of parents who participated in the study until the last stage of the protocol, number of parents who dropped out of the study and reason.
Measured: at the last protocol visit ( visit 6 - day 180)
Secondary outcomes (5)
Parental stress Evolution
Evolution of parental stress by the ISP-4 self-questionnaire (Parental Stress Index)
Measured: between visit 1 (day -28) and visit 6 (day 180)
Infant development
Evolution of the overall score of the Bayley-4 scale (Bayley Infant and Young Child Development Scales) at 6 months of life compared to a literature cohort (neonate child).
Measured: at the last protocol visit ( visit 6 - day 180)
Evaluation of the healthcare team adherence
Evaluation of the adherence of the healthcare team to this new model via a Likert scale administered at the discharge of the child, and an analysis of the large items found on the accompanying sheets
Measured: at visit 5 ( day 60 )
Evaluation of the healthcare team adherence
Evaluation of the adherence of the healthcare team to this new model via an EVA scale administered at the discharge of the child, and an analysis of the large items found on the accompanying sheets
Measured: at visit 5 ( day 60 )
Personal Support Project Evaluation
Evaluation of the Personal Support Project by families using an Visual Analogue Scale.
Measured: at the last protocol visit ( visit 6 - day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start6 Feb 2025
- Primary completion6 Feb 2027 (estimated)
- Study completion6 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884046
- Sponsor's protocol ID
- CHUBX 2022/78
- Other IDs
- 2024-A00681-46
- Acronym
- Et APRéS Ca
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT06884046
- Acronym / sponsor ID
- Et APRéS Ca / CHUBX 2022/78
- Conditions
- Complex Congenital Heart Disease
- Keywords
- Neurodevelopment, Stress parental, Parental guidance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 6 Feb 2027 (estimated)
- Study completion
- 6 Feb 2027 (estimated)
- First posted
- 19 Mar 2025 (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.
Half of children with congenital heart disease develop specific neurodevelopmental disorders. Neurodevelopmental disorders are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. The stress perceived by parents of children with congenital heart disease varies depending on the time of diagnosis, the organization of care inherent in neonatal management and the type of pathology diagnosed.
The main objective is to evaluate the feasibility of a multidisciplinary and personalised model of support for parental stress, from the ante-natal period, in the context of their child's neonatal cardiac surgery.
Detailed description
Congenital heart disease (CC) is the most common congenital malformation. Every year, 8 newborns out of 1000 are affected by these pathologies worldwide and about 20% of them will require intervention in the first days of life. The complexity of heart disease, factors intrinsic to the patient as well as surgical techniques can be the cause of neurological abnormalities. Indeed, 43% of these CC newborns are already carriers of a cerebral anomaly in the perinatal period.
Neurodevelopmental disorders (NDD) are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. The stress perceived by parents of children with CC varies depending on the time of diagnosis, the type of pathology and the organization of neonatal care.
It is essential to accompany these parents with personalized care. It must be comprehensive, multidisciplinary and empathetic, with the aim of improving the neurodevelopmental prognosis of these children, and family well-being.
Through this project of accompaniment proposed from the antenatal, we innovate by integrating consultations by the paramedical team of the resuscitation, the implementation of a personalized support project that meets the expectations and needs of families for better care of their child. A parental stress assessment will be carried out at 4 times of the family care journey.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accompaniment project | Experimental | Other: Personalized support projectThe experimental intervention envisaged combines specific monitoring and the implementation of a personalised support programme. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents whose fetus has congenital heart disease diagnosed in antenatal, which will be operated in the neonatal period (between 0 and 28 days of life) within our sector.
- Parents followed in the congenital heart disease sector of the University Hospital of Bordeaux as soon as the diagnosis is announced in antenatal.
- Free, informed and signed written consent of the couple or single mother in a single parent setting or by a third person (in case of physical disability of the participant) and the investigator (no later than the day of inclusion and before any examination required by the research).
- Person affiliated or beneficiary of a social security scheme (excluding AME).
- Parents with parental authority.
Key exclusion criteria (4 listed)
- Parents who do not understand or read French and cannot be accompanied by a third party for translation.
- Parents with major psychiatric disorders.
- Parents deprived of liberty due to ongoing legal proceedings.
- Parents under guardianship or curatorship or unable to personally express consent.
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 |
|---|---|---|
| Personalized support project1. Presence of a child nurse at the consultation of the anesthesiologist-resuscitator. 2. Antenatal paramedical consultation conducted by a child nurse composed of a semi-structured interview and an evaluation of Parental Stress by the ISP-4 self-questionnaire. 3. Implementation of the personalized support project 4. Self-assessment of parental stress using the ISP-4 self-questionnaire (child admitted to intensive care or resuscitation unit) 5. Application of the personalised support project 6. Self-assessment of parental stress using the ISP-4 self-questionnaire (child discharged from intensive care) 7. Paramedical follow-up consultation with parents (semi-directive interview, ISP-4 self-questionnaire) and assessment of the child's psychomotor development in the child's 6th month of life | Other | Accompaniment project |
Primary outcome
Families participation evaluation
Time frame: at the last protocol visit ( visit 6 - day 180)
The participation of families in the proposed accompaniment will be evaluated by the participation rate: number of parents who participated in the study until the last stage of the protocol, number of parents who dropped out of the study and reason.
5 secondary outcomes
Parental stress Evolution
Time frame: between visit 1 (day -28) and visit 6 (day 180)
Infant development
Time frame: at the last protocol visit ( visit 6 - day 180)
Evaluation of the healthcare team adherence
Time frame: at visit 5 ( day 60 )
Evaluation of the healthcare team adherence
Time frame: at visit 5 ( day 60 )
Personal Support Project Evaluation
Time frame: at the last protocol visit ( visit 6 - day 180)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized support project in people with Complex Congenital Heart Disease, run by University Hospital, Bordeaux 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 5 inclusion and 4 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 19 Mar 2025. 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 Laurie PONTEINS (+33 05 57 65 67 93 ext. +33, laurie.ponteins@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Families participation evaluation (time frame: at the last protocol visit ( visit 6 - day 180)). 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 19 Mar 2025.