The CHILD Trial: Hypoplastic Left Heart Syndrome Study. (NCT03406884) | Clinical Trial Compass
CompletedPhase 1
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
United States25 participantsStarted 2019-10-16
Plain-language summary
The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality.
Who can participate
Age range
1 Day – 21 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects with hypoplastic left heart syndrome (HLHS) (all types) requiring Stage I Norwood operation.
Exclusion criteria
. Subjects undergoing the Stage I Norwood operation who do not have HLHS.
. Subjects requiring mechanical circulatory support immediately prior to Stage II BDCPA operation (within 5 days).
. Parent or guardian unwilling or unable to comply with necessary follow-up(s).
. Mother is serum positive for HIV 1/2, hepatitis B surface antigen or viremic hepatitis C and Treponema pallidum.
. Subjects who are unsuitable for inclusion in the study in the opinion of the investigator(s).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Incidence of Treatment Related Major Adverse Cardiac Events
Timeframe: 30 days
2
Number of C-kit+ Products
Timeframe: Day 1
3
Number of Participants Completing Magnetic Resonance Imaging (MRI)
Timeframe: Baseline, 6 Months, 12 months
4
Change in Right Ventricular Function (RVEF)
Timeframe: Baseline, 6 Months, 12 months
5
Change in Right Ventricular End-diastolic Volume (RVEDV)
Timeframe: Baseline, 6 months, 12 months
6
Change in Right Ventricular End-systolic Volume (RVESV)