Abstract

This protocol will study congenital cytomegalovirus infection in infants with symptomatic central nervous system involvement. In patients who are randomized to the treatment arm, hospitalization will be for the duration of the treatment phase. The treatment phase will be a minimum of 42 days and will involve close clinical monitoring as well as frequent laboratory studies. CBC#4, reticulocyte counts, renal/liver function studies and urinalysis will be done 12 times each as well as other tests to monitor potential drug toxicities. Baseline assessments include CAT scan of head, audiological, brain stem evoked response and Denver Developmental Assesment. The use of the GCRC makes possible evaluation of potential benefits/risks of the use of DHPG in the treatment of congenital CMV infection in this extremely complicated protocol. Non-treated patients will be seen weekly for seven weeks. In addition to laboratory specimens collected at each weekly visit, long-term follow-up for both arms of the study include appropriate audiological asessments, opthalmalogic assessments and developmental assessments through at lease the child's fifth year.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000032-42
Application #
6565409
Study Section
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
42
Fiscal Year
2002
Total Cost
Indirect Cost

  Institution

Name
University of Alabama Birmingham
Department
Type
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294

  Publications

Yu, Alan S L; Shen, Chengli; Landsittel, Douglas P et al. (2018) Baseline total kidney volume and the rate of kidney growth are associated with chronic kidney disease progression in Autosomal Dominant Polycystic Kidney Disease. Kidney Int 93:691-699
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
McKenzie, Katelyn A; El Ters, Mirelle; Torres, Vicente E et al. (2018) Relationship between caffeine intake and autosomal dominant polycystic kidney disease progression: a retrospective analysis using the CRISP cohort. BMC Nephrol 19:378
Denson, Lee A; McDonald, Scott A; Das, Abhik et al. (2017) Early Elevation in Interleukin-6 is Associated with Reduced Growth in Extremely Low Birth Weight Infants. Am J Perinatol 34:240-247
Kline, Timothy L; Korfiatis, Panagiotis; Edwards, Marie E et al. (2017) Image texture features predict renal function decline in patients with autosomal dominant polycystic kidney disease. Kidney Int 92:1206-1216
James, Jennifer; Munson, David; DeMauro, Sara B et al. (2017) Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support. J Pediatr 190:118-123.e4
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Morrison, Shannon A; Goss, Amy M; Azziz, Ricardo et al. (2017) Peri-muscular adipose tissue may play a unique role in determining insulin sensitivity/resistance in women with polycystic ovary syndrome. Hum Reprod 32:185-192
Shen, Chengli; Landsittel, Douglas; Irazabal, María V et al. (2017) Performance of the CKD-EPI Equation to Estimate GFR in a Longitudinal Study of Autosomal Dominant Polycystic Kidney Disease. Am J Kidney Dis 69:482-484

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