Status:
NOT_YET_RECRUITING
Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
CHD - Congenital Heart Disease
Eligibility:
All Genders
Up to 12 years
Phase:
NA
Brief Summary
Actually, there is no telemonitoring program that includes newborns or infants with congenital heart disease awaiting cardiac intervention. This is a vulnerable period, prone to clinical complications...
Detailed Description
Today, congenital heart disease affects around 0.8% of births in France. One third of children diagnosed antenatally or postnatally with congenital heart disease will require surgical or percutaneous ...
Eligibility Criteria
Inclusion
- Newborns and/or infants aged 0 to 12 months inclusive at the time of diagnosis.
- With congenital heart disease as defined in the ICD-11 classification.
- Waiting for an intervention by cardiac surgery or interventional catheterization.
- Free, informed consent signed by the holder(s) of parental authority.
- Person affiliated to or benefiting from a social security scheme.
Exclusion
- Short-term vital prognosis
- Clinical situation identified at the M3C RCP that contraindicates a return home
- Family situation identified at the M3C RCP as contra-indicating a return home
- Extra-cardiac co-morbidities requiring hospitalisation independent of the heart disease (e.g. severe renal failure, neurological deficit, complex immune deficiency, etc.).
- Limited understanding of parental authority holder(s) / caregivers (non-French speaking, hearing impaired, cognitive impairment or other)
- Parents unable to give informed consent.
- Minors with parental authority
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06998290
Start Date
June 1 2025
End Date
June 1 2027
Last Update
May 31 2025
Active Locations (2)
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1
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, France, 34295 - Cedex 5
2
CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque
Pessac, France, France, 33604