NCT06998290

Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life

Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

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, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. The aim of the study is to assess the feasibility and acceptability of monitoring newborns and infants with congenital heart disease awaiting cardiac surgery using the Blue-Line home telemonitoring program.

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 intervention within the first year of life. 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, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. Our research team at the M3C Network Reference Center aims to develop home telemonitoring for these patients, in order to innovate and optimize their care pathway.

Conditions

• CHD - Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Blue-Line home telemonitoring program	* A dedicated telemonitoring team with nurses and pediatric cardiologist * A dedicated therapeutic patient education programme * A home telemonitoring medical device with a dedicated platform

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

2 sites across 1 country: France