Cardiopediatric Home Monitoring Tool

NCT06741189 | Not Yet Recruiting

• 1 other identifier: RC24_0146
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

We hypothesize that a home monitoring program combined with routine postoperative care significantly reduces morbidity and mortality after neonatal and pediatric cardiac surgery. This project differs from the previously published experiences by (a) providing an innovative telemedicine solution via the use of validated measurement sensors, (b) an alert system based on individualized standards, established for each care pathway, and (c) a protocolized response from medical teams in the management of alerts generated by the home monitoring tool.

Conditions

Congenital Heart Defect

Keywords

Congenital heart defects, cardiac surgery, care pathway, home monitoring, morbidity and mortality

Outcome Measures

Primary Outcomes (1)

• Reducing postoperative morbidity and mortality

  The main objective is to evaluate the impact of home monitoring in reducing postoperative morbidity and mortality in patients aged 0 to 36 months who have undergone MCC.

  6th month post-op

Secondary Outcomes (11)

• Children's quality of life

  0,1 month, 3 months and 6 months post op

• Parents' quality of life

  0,1 month, 3 months and 6 months post op

• Parental stress

  0,1 month, 3 months and 6 months post op

• Children's weight growth

  1 month, 3 months and 6 months post op

• Post-traumatic stress syndromes

  6 months post op

Study Arms (2)

standard group

ACTIVE COMPARATOR

The usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of : 1. during the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram. 2. during the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures.

Other: usual medical monitoring

home monitoring group

EXPERIMENTAL

In addition to the usual post-operative monitoring, OSCAR home monitoring will enable key parameters to be transmitted to the medical team at a discontinuous rate (once a day for 4 weeks, then once a week for 20 weeks) via a brief questionnaire (smartphone application) and measurement sensors (weight, oxygen saturation, heart rate) linked to an interface, from the first day the patient returns home until the 6th month post-operatively. The values entered will be automatically compared with individualized standards established for each child at a multidisciplinary meeting, and any deviation from the standard will generate an alert. and the response of the medical teams will be protocolized.

Other: Home monitoring; Other: usual medical monitoring

Interventions

Home monitoring OTHER

The key parameters (heart rate, arterial oxygen saturation, weight) will be measured at home using the measurement tools used by the parents, and tele-transmitted at a discontinuous rate, i.e. once a day for 4 weeks, then once a week for 20 weeks. The measurement tools will be given to the family before discharge from the hospital ward. These parameters will be entered into the Exolis platform, in addition to a very brief questionnaire designed to provide information about the child's diet, muscle tone and any medication he or she is taking. taken by the child. An alert will be automatically generated for the pediatric cardiology team if the data transmitted by the measurement sensors deviates from an individualized standard, defined for each child and/or each care pathway at the multidisciplinary consultation meeting before the child returns home. The response will be standardized on the basis of a protocol shared by the 4 investigating centers.

home monitoring group

usual medical monitoring OTHER

During the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram. During the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures.

home monitoring group; standard group

Eligibility Criteria

• Age: 0 Minutes - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged between 0 and 36 months inclusive
• With a congenital heart defect
• Underwent cardiac surgery at Nantes University Hospital
• Affiliated to a social security scheme
• Free, informed and written consent of the 2 holders of parental authority
• Clinical or family situation contraindicating a return home
• Physical inability to connect to the Exolis platform at home
• Insufficient understanding on the part of those with parental authority
• Extracardiac co-morbidities responsible for organ failure requiring repeated
• Hospitalisation for non-cardiovascular reasons (e.g. severe renal failure, neurological neurological deficit, complex immune deficiency, etc).
• Patient and/or parents under legal protection

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Central Study Contacts

Alban-Elouen Baruteau, Pr

CONTACT

+33; albanelouen.baruteau@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: September 11, 2025
• Primary Completion (Estimated): December 11, 2027
• Study Completion (Estimated): December 11, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09