Exploring Precision Medicine in the CICU: Feasibility of Proteomic Biomarkers
New trial seeks to predict heart surgery complications in children using blood tests.
Plain English Summary
Precision Medicine in the CICU: Identifying Proteomic Biomarkers is a Not Applicable clinical trial sponsored by Boston Children's Hospital studying Congenital Heart Disease. This study aims to identify specific proteins in the blood that can predict how a child will recover after heart surgery. It is for children aged 1-5 years undergoing specific types of heart repair surgery. Participation involves providing blood samples before and after surgery for detailed protein analysis. Currently, doctors use a general approach to care after surgery, but this trial hopes to personalize it. The trial aims to enroll 60 participants.
Official Summary
Congenital Heart disease (CHD) is a leading cause of childhood death. Substantial morbidity and mortality relates to the postoperative course. For example, only 70% of neonates survive to hospital discharge after their first complex surgery for single ventricle heart disease. Adverse systemic inflammatory responses are highly exaggerated in some children postoperatively. This inflammation is pathological, results in leaky blood vessels and fluid overload, toxin release as well as cell damage contributing to lung, heart and kidney injury. Reasons why some children develop this amplified systemic inflammatory response after heart surgery while others do not are poorly understood. Mechanisms for how cardiopulmonary bypass and surgery drive this inflammation are also inadequately characterized. Currently, there are no existing methods to predict patients at high-risk for acute adverse postoperative complications, let alone adjust our management to mitigate these effects. Instead, our postoperative care approach is a one-size fits all, reactive process 'after' patients become inflamed or adverse events occur. Proteins in a patient's blood participate in and reflect acute inflammatory responses. In other pediatric conditions, protein biomarkers have been shown to both predict and monitor inflammation and adverse outcomes, and importantly predict responsiveness to anti-inflammatory drug therapies. This is the premise of precision medicine. Personalizing treatment to each individual patient. New technologies now allow the levels of tens of thousands of proteins to be measured from a few drops of blood. In this proposal the investigators will identify predictors of adverse events after heart surgery by quantifying protein levels and their changes after surgery. It is now possible to detect those proteins with the greatest variability in the postoperative course over time, and between patients, as well as those that are associated with adverse outcomes. The most informative
Who Can Participate
Here is what you need to know about eligibility for this trial. Children aged 1 to 5 years who are scheduled for specific types of heart repair surgery. Parents or guardians must provide consent for their child's participation. Children cannot have been on a breathing machine, receiving certain medications to support blood pressure, or on life support (ECMO) before surgery. This trial is studying Congenital Heart Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how quickly a child can breathe on their own after surgery, helping doctors understand the immediate impact of the surgery and recovery. The specific primary outcome measures are: Time in hours to successful extubation (through ICU admission, average 1 week). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to fill a gap in predicting and preventing severe inflammation and organ damage after complex heart surgeries in children, potentially leading to more personalized c This research targets Congenital Heart Disease, where improved treatment options are needed.
Investor Insight
This trial explores a precision medicine approach for a significant pediatric condition, potentially leading to better patient outcomes and a more targeted market for diagnostic tools and therapies.
Is This Trial Right for Me?
Ask your doctor if your child is a candidate and what the specific surgery involves. Understand that blood samples will be collected at different times around the surgery. Be prepared for standard post-operative care alongside the study procedures. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 60 participants
Interventions
- DIAGNOSTIC_TEST: Somascan 5.0 — This observational study will test patient plasma using the SomaScan platform, a highly multiplexed proteomic tool that uses SOMAmers (Slow Off-rate Modified Aptamers) to bind with high specificity and affinity to preselected proteins to quantify levels. SomaScan v5.0 quantifies 10,778 clinically relevant human proteins, with several thousand proteins linked to inflammation and immune system functions, across a wide range of concentrations (\>10 logs) with high sensitivity (\<1 pg/mL) and reprod
Primary Outcomes
- Time in hours to successful extubation (through ICU admission, average 1 week)
Secondary Outcomes
- Extent of fluid overload (3 days)
- Composite adverse outcome (7 days)
Full Eligibility Criteria
Inclusion Criteria: * consent from parents * cardiac surgical criteria and age criteria; elective BiV repair in patients aged \>1 and \<5 years or standard risk S1P/ASO Exclusion Criteria: * preoperative ventilation or vasoactive support or ECMO
Trial Locations
- Boston Children's Hospital, Boston, Massachusetts, United States
Frequently Asked Questions
What is clinical trial NCT06642662?
NCT06642662 is a Not Applicable OBSERVATIONAL study titled "Precision Medicine in the CICU: Identifying Proteomic Biomarkers." It is currently enrolling by invitation and is sponsored by Boston Children's Hospital. The trial targets enrollment of 60 participants.
What conditions does NCT06642662 study?
This trial investigates treatments for Congenital Heart Disease. The primary condition under study is Congenital Heart Disease.
What treatments are being tested in NCT06642662?
The interventions being studied include: Somascan 5.0 (DIAGNOSTIC_TEST). This observational study will test patient plasma using the SomaScan platform, a highly multiplexed proteomic tool that uses SOMAmers (Slow Off-rate Modified Aptamers) to bind with high specificity and affinity to preselected proteins to quantify levels. SomaScan v5.0 quantifies 10,778 clinically relevant human proteins, with several thousand proteins linked to inflammation and immune system functions, across a wide range of concentrations (\>10 logs) with high sensitivity (\<1 pg/mL) and reprod
What does Not Applicable mean for NCT06642662?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06642662?
This trial is currently "Enrolling by Invitation." It started on 2025-04-15. The estimated completion date is 2027-04-15.
Who is sponsoring NCT06642662?
NCT06642662 is sponsored by Boston Children's Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06642662?
The trial aims to enroll 60 participants. The trial status is enrolling by invitation.
How is NCT06642662 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06642662?
The primary outcome measures are: Time in hours to successful extubation (through ICU admission, average 1 week). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06642662 being conducted?
This trial is being conducted at 1 site, including Boston, Massachusetts (United States).
Where can I find official information about NCT06642662?
The official record for NCT06642662 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06642662. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06642662 testing in simple terms?
This study aims to identify specific proteins in the blood that can predict how a child will recover after heart surgery. It is for children aged 1-5 years undergoing specific types of heart repair surgery.
Why is this trial significant?
This trial matters because it aims to fill a gap in predicting and preventing severe inflammation and organ damage after complex heart surgeries in children, potentially leading to more personalized c
What are the potential risks of participating in NCT06642662?
The main risk is related to blood draws, which can cause minor discomfort or bruising. There are no experimental treatments involved, only observation and sample collection. Potential risks are those associated with the child's specific heart condition and surgery. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06642662?
Ask your doctor if your child is a candidate and what the specific surgery involves. Understand that blood samples will be collected at different times around the surgery. Be prepared for standard post-operative care alongside the study procedures. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06642662 signal from an investment perspective?
This trial explores a precision medicine approach for a significant pediatric condition, potentially leading to better patient outcomes and a more targeted market for diagnostic tools and therapies. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood samples before and after surgery for detailed protein analysis. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.