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Author Notes:

See publication for full list of authors and contributions.

We acknowledge the hard work of the Pediatric Heart Network coordinators including Katherine Afton, Carolyn Dunbar-Masterson, Lisa Jean Buckley, Kathy Lupton, Michelle Otto, Regina Cole, Michelle Hamstra, Madison Rudow, Katrina Golub, Chanel Rojas, Mingfen Xu, Kalyan Chundru


Research Funding:

This work was supported by grants from the National Heart, Lung, and Blood Institute (HL135680, HL135685, HL135683, HL135689, HL135691, HL135646, HL135665, HL135678, HL135682, and HL135666). AP was supported by the Department of Defense (W81XWH-16-1-0613), the National Heart, Lung and Blood Institute (R01 HL152740-1, R01 HL128818-05), a Society for Pediatric Radiology Multi-Institutional Pilot Award and Additional Ventures.

Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes: Design, Recruitment, and Technical Challenges of a Multicenter, Observational Neuroimaging Study.


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Type of Work:

Article | Preprint: Prior to Peer Review


UNLABELLED: Patients with hypoplastic left heart syndrome who have been palliated with the Fontan procedure are at risk for adverse neurodevelopmental outcomes, lower quality of life, and reduced employability. We describe the methods (including quality assurance and quality control protocols) and challenges of a multi-center observational ancillary study, SVRIII (Single Ventricle Reconstruction Trial) Brain Connectome. Our original goal was to obtain advanced neuroimaging (Diffusion Tensor Imaging and Resting-BOLD) in 140 SVR III participants and 100 healthy controls for brain connectome analyses. Linear regression and mediation statistical methods will be used to analyze associations of brain connectome measures with neurocognitive measures and clinical risk factors. Initial recruitment challenges occurred related to difficulties with: 1) coordinating brain MRI for participants already undergoing extensive testing in the parent study, and 2) recruiting healthy control subjects. The COVID-19 pandemic negatively affected enrollment late in the study. Enrollment challenges were addressed by 1) adding additional study sites, 2) increasing the frequency of meetings with site coordinators and 3) developing additional healthy control recruitment strategies, including using research registries and advertising the study to community-based groups. Technical challenges that emerged early in the study were related to the acquisition, harmonization, and transfer of neuroimages. These hurdles were successfully overcome with protocol modifications and frequent site visits that involved human and synthetic phantoms. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registration Number: NCT02692443.

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This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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