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Chest Wall Mechanics Study for Heart Disease

N/A

Waitlist Available

Led By Luciana Rodriguez Guerineau, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergone surgery using CPB for congenital heart disease

Aged <28 days of life at the time of cardiac surgery

Must not have

Pre-existing or new arrhythmia that can impact hemodynamic assessment

Gestational age < 37 weeks or weight < 2 kg at the time of surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days post-operation or discharge (whichever comes first)

Awards & highlights

No Placebo-Only Group

Summary

This trialstudies how babies' chest walls move during delayed sternal closure surgery after heart surgery or treatment.

Who is the study for?

This trial is for newborns under 28 days old who have had surgery for congenital heart disease and need their chest kept open in the critical care unit. They must weigh over 2 kg, be at least full-term babies, and not require certain advanced respiratory or circulatory support.

What is being tested?

The study tests how different breathing machine settings affect the chest wall during delayed sternal closure after heart surgery. It uses a special catheter to measure pressure inside the esophagus of these infants.

What are the potential side effects?

Potential side effects may include discomfort from the catheter placement, risk of infection at the insertion site, and possible interference with normal breathing patterns due to measurement procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had heart surgery with a heart-lung machine for a birth defect.

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My baby was younger than 28 days old at the time of their heart surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart rhythm problem that affects my blood flow.

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My baby was born before 37 weeks or weighed less than 2 kg at surgery time.

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I require a machine to help with my heart and lungs function.

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I have a lung condition I was born with.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to and immediately after sternal chest wall closure procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to and immediately after sternal chest wall closure procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and immediately after sternal chest wall closure procedure for reporting.