Chest Wall Mechanics Study for Heart Disease
Palo Alto (17 mi)Overseen byLuciana Rodriguez Guerineau, MD
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: The Hospital for Sick Children
No Placebo Group
Trial Summary
What is the purpose of this trial?This study aims to describe chest wall mechanics during delayed sternal closure (DSC) in neonates following cardiopulmonary bypass or palliation of congenital heart diseases.
Eligibility Criteria
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.Inclusion Criteria
I had heart surgery with a heart-lung machine for a birth defect.
My baby was younger than 28 days old at the time of their heart surgery.
Exclusion Criteria
I have a heart rhythm problem that affects my blood flow.
My baby was born before 37 weeks or weighed less than 2 kg at surgery time.
I require a machine to help with my heart and lungs function.
I have a lung condition I was born with.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Group I: Univentricular physiologyExperimental Treatment1 Intervention
Neonates with univentricular physiology
Group II: Biventricular physiologyExperimental Treatment1 Intervention
Neonates with biventricular physiology
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Hospital for Sick ChildrenToronto, Canada
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
Children's Hospital Los AngelesCollaborator