Chest Wall Mechanics Study for Heart Disease
Recruiting in Palo Alto (17 mi)
Overseen byLuciana Rodriguez Guerineau, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
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
Having a drug screening test in a specialized care unit.
I had heart surgery with a heart-lung machine for a birth defect.
Informed consent provided by parent or primary guardian
+1 more
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.
You have a severe blood clotting problem or a condition that makes it unsafe to insert a tube through your nose into your stomach.
+3 more
Participant Groups
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