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Chest Wall Mechanics Study for Heart Disease

Q: Are there any vacancies for prospective participants in this clinical trial?

<p>Reports on clinicaltrials.gov confirm that this trial is presently looking for participants, with initial posting occurring on August 1st 2022 and the most recent update made on October 26th 2022.</p>

Q: How many individuals are involved in the current research endeavor?

<p>Affirmative. Clinicaltrials.gov contains evidence that the trial is actively searching for volunteers to take part; this endeavour was initially posted on August 1st of 2022 and has been recently revised on October 26th, 2022. The project requires 40 participants from a single site.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of patients with successful insertion and measurement of esophageal pressures

Secondary outcome measures

Changes in transmural pressures

Chest wall and lung compliance

Duration of inotropic support

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Univentricular physiologyExperimental Treatment1 Intervention

Neonates with univentricular physiology

Group II: Biventricular physiologyExperimental Treatment1 Intervention

Neonates with biventricular physiology

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

686 Previous Clinical Trials

6,944,753 Total Patients Enrolled

Children's Hospital Los AngelesOTHER

232 Previous Clinical Trials

5,076,728 Total Patients Enrolled

Luciana Rodriguez Guerineau, MDPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Univentricular physiology Clinical Trial Eligibility Overview. Trial Name: NCT05257525 — N/A

Neonatal Delayed Sternal Closure Research Study Groups: Univentricular physiology, Biventricular physiology

Neonatal Delayed Sternal Closure Clinical Trial 2023: Univentricular physiology Highlights & Side Effects. Trial Name: NCT05257525 — N/A

Univentricular physiology 2023 Treatment Timeline for Medical Study. Trial Name: NCT05257525 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for prospective participants in this clinical trial?

"Reports on clinicaltrials.gov confirm that this trial is presently looking for participants, with initial posting occurring on August 1st 2022 and the most recent update made on October 26th 2022."

Answered by AI

How many individuals are involved in the current research endeavor?

"Affirmative. Clinicaltrials.gov contains evidence that the trial is actively searching for volunteers to take part; this endeavour was initially posted on August 1st of 2022 and has been recently revised on October 26th, 2022. The project requires 40 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure

Luciana Rodriguez Guerineau 2022. "Impact of Chest Wall Mechanics on Lung and Cardiovascular Function During Delayed Sternal Closure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05257525.