An interventional study of Personalized support project in Complex Congenital Heart Disease, sponsored by University Hospital, Bordeaux. Recruiting at 1 site in France. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The experimental intervention envisaged combines specific monitoring and the implementation of a personalised support programme.
Other: Personalized support project
1. 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
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.
Time frame: at the last protocol visit ( visit 6 - day 180)
Parental stress Evolution
Evolution of parental stress by the ISP-4 self-questionnaire (Parental Stress Index)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: at visit 5 ( day 60 )
Personal Support Project Evaluation
Evaluation of the Personal Support Project by families using an Visual Analogue Scale.
Time frame: at the last protocol visit ( visit 6 - day 180)
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University Hospital, Bordeaux