The CHILD Trial: Hypoplastic Left Heart Syndrome Study.

Completed · Phase 1

Conditions studied: Hypoplastic Left Heart Syndrome

In brief

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.

Key facts

Study ID

NCT03406884

Run by

Joshua M Hare

People needed

25

Starts

2019-10-16

Expected to finish

2024-07-01

Last updated by the study team

2026-01-23

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the study, subjects must meet all of the inclusion criteria:
• Subjects with hypoplastic left heart syndrome (HLHS) (all types) requiring Stage I Norwood operation.

You may not qualify if…

• Candidates will be excluded from the study if any of the following conditions are met:
• 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).

Where it is running

• Emory University Children's Healthcare of Atlanta - Egleston Campus — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Maryland - Division of Cardiac Surgery — Baltimore, Maryland, United States
• Michigan Medicine Congenital Heart Center/C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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