Kidney Transplantation Clinical Trial
Official title:
Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients
Verified date | November 2020 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions.
Status | Terminated |
Enrollment | 57 |
Est. completion date | November 1, 2020 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility | Inclusion Criteria: - between newborn and 21 years old - parent/child pairs of patients listed for or who have received a liver transplant, kidney transplant, or heart transplant Exclusion Criteria: - unwilling or unable to participate - not in one of the above transplant groups - non-English speaking |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Cole CR, Bucuvalas JC, Hornung RW, Krug S, Ryckman FC, Atherton H, Alonso MP, Balistreri WF, Kotagal U. Impact of liver transplantation on HRQOL in children less than 5 years old. Pediatr Transplant. 2004 Jun;8(3):222-7. — View Citation
Forsyth BW, Horwitz SM, Leventhal JM, Burger J, Leaf PJ. The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability. J Pediatr Psychol. 1996 Feb;21(1):89-101. — View Citation
Freier MC, Babikian T, Pivonka J, Burley Aaen T, Gardner JM, Baum M, Bailey LL, Chinnock RE. A longitudinal perspective on neurodevelopmental outcome after infant cardiac transplantation. J Heart Lung Transplant. 2004 Jul;23(7):857-64. — View Citation
Goldstein SL, Graham N, Burwinkle T, Warady B, Farrah R, Varni JW. Health-related quality of life in pediatric patients with ESRD. Pediatr Nephrol. 2006 Jun;21(6):846-50. Epub 2006 Apr 20. — View Citation
Green A, McSweeney J, Ainley K, Bryant J. In my shoes: children's quality of life after heart transplantation. Prog Transplant. 2007 Sep;17(3):199-207; quiz 208. — View Citation
Manificat S, Dazord A, Cochat P, Morin D, Plainguet F, Debray D. Quality of life of children and adolescents after kidney or liver transplantation: child, parents and caregiver's point of view. Pediatr Transplant. 2003 Jun;7(3):228-35. — View Citation
Mussatto K, Tweddell J. Quality of life following surgery for congenital cardiac malformations in neonates and infants. Cardiol Young. 2005 Feb;15 Suppl 1:174-8. Review. — View Citation
Pollock-BarZiv SM, Anthony SJ, Niedra R, Dipchand AI, West LJ. Quality of life and function following cardiac transplantation in adolescents. Transplant Proc. 2003 Nov;35(7):2468-70. — View Citation
Roy, C., & Andrews, H. A. (1991). The roy adaptation model: The definitive statement. East Norwalk, Connecticut: Prentice Hall.
Schulz KH, Wein C, Boeck A, Rogiers X, Burdelski M. Cognitive performance of children who have undergone liver transplantation. Transplantation. 2003 Apr 27;75(8):1236-40. — View Citation
Stuber ML. Psychiatric aspects of organ transplantation in children and adolescents. Psychosomatics. 1993 Sep-Oct;34(5):379-87. Review. — View Citation
Sweet SC, Wong HH, Webber SA, Horslen S, Guidinger MK, Fine RN, Magee JC. Pediatric transplantation in the United States, 1995-2004. Am J Transplant. 2006;6(5 Pt 2):1132-52. — View Citation
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. — View Citation
Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. — View Citation
Wray J, Radley-Smith R. Beyond the first year after pediatric heart or heart-lung transplantation: Changes in cognitive function and behaviour. Pediatr Transplant. 2005 Apr;9(2):170-7. — View Citation
Wray J, Radley-Smith R. Depression in pediatric patients before and 1 year after heart or heart-lung transplantation. J Heart Lung Transplant. 2004 Sep;23(9):1103-10. — View Citation
Wray J, Radley-Smith R. Longitudinal assessment of psychological functioning in children after heart or heart-lung transplantation. J Heart Lung Transplant. 2006 Mar;25(3):345-52. Epub 2006 Jan 18. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pediatric Quality of Life Inventory | every 6 months | ||
Secondary | Peds QL Family Impact Module | every 6 months | ||
Secondary | Peds QL Family Information Form | every 6 months | ||
Secondary | Functional Status II-R | every 6 months | ||
Secondary | Child Vulnerability Scale | every 6 months |
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