Ethics Approval and Consent to Participate
Written informed consent was obtained from patients on their guardians prior to inclusion in the study. The study was approved by the Institutional Review Boards at all participating sites.
Consent for Publication
Not Applicable
Availability of data and materials
The data that support the findings of this study are available from the RESTORE study but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of the RESTORE study.
Competing interests
The authors have declared that they have no conflict of interest exists.
Funding
R01HL095410 awarded to Drs. Sapru, Dahmer, Flori and Quasney, HL123004, HL140026 awarded to Dr. Matthay, 2T32HL072752-16 awarded to Dr. Monteiro, and R01 HL0114484 awarded to Dr. Sapru. The parent study was supported by grants from the NIH awarded to Drs. Curley and Wypij (U01HL086622, U01 HL086649).
Author contributions
ACCM wrote the manuscript and analyzed the data, HF, MKD and AS conceptualized the study, collected the data and performed significant editing of the manuscript, MSS performed the statistical analysis, MWQ, MAQC conceptualized the parent study and performed significant editing of the manuscript, MAM performed significant editing of the manuscript.
Acknowledgments
We would like to thank all the patients and guardians of those patients for their participation in the study. We would also like to acknowledge the contribution of the BALI study investigators at the sites that participated in the RESTORE study including: Scot T. Bateman (University of Massachusetts Memorial Children's Medical Center, Worcester, MA), M. D. Berg (University of Arizona Medical Center, Tucson, AZ), Santiago Borasino (Children’s Hospital of Alabama, Birmingham, AL), G. Kris Bysani (Medical City Children's Hospital, Dallas, TX), Allison S. Cowl (Connecticut Children's Medical Center, Hartford, CT), Cindy Darnell Bowens (Children’s Medical Center of Dallas, Dallas, TX), E. Vincent S. Faustino (Yale-New Haven Children’s Hospital, New Haven, CT), Lori D. Fineman (University of California San Francisco Benioff Children’s Hospital at San Francisco, San Francisco, CA), A. J. Godshall (Florida Hospital for Children, Orlando, FL), Ellie Hirshberg (Primary Children’s Medical Center, Salt Lake City, UT), Aileen L. Kirby (Oregon Health & Science University Doernbecher Children's Hospital, Portland, OR), Gwenn E. McLaughlin (Holtz Children’s Hospital, Jackson Health System, Miami,FL), Shivanand Medar (Cohen Children's Medical Center of New York, Hyde Park, NY), Phineas P. Oren (St. Louis Children’s Hospital, St. Louis, MO), James B. Schneider (Cohen Children's Medical Center of New York, Hyde Park, NY), Adam J. Schwarz (Children’s Hospital of Orange County, Orange, CA), Thomas P. Shanley (C. S. Mott Children’s Hospital at the University of Michigan, Ann Arbor, MI), Lauren R. Sorce (Ann & Robert H. Lurie, Children’s Hospital of Chicago, Chicago, IL), Edward J. Truemper (Children’s Hospital and Medical Center, Omaha, NE), Michele A. Vander Heyden (Children's Hospital at Dartmouth, Dartmouth, NH), Kim Wittmayer (Advocate Hope Children’s Hospital, IL), Athena Zuppa (Children’s Hospital of Philadelphia, Philadelphia, PA) and the RESTORE data coordination center led by David Wypij, PhD (Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts; Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts).