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Clinical Trial Details

Title
A Four-Year Blinded-Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204 (A 48-52 Month Blinded-Outcomes Follow-up Study of Patients Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-205)
Study Purpose
The purpose of this study is to continue observation of those babies who had newborn jaundice and were enrolled in clinical trial 64,185-204.
Study Plan
Subjects took part in clinical trial 64,185-204 and you are now being asked to participate in the follow-up research study to check their health over approximately the next 4 years. No new medicine is involved in this follow up study. This clinical trial will consist of two phone calls (at 6 months and 3 years of age) and three follow-up visits (at 1 year 2 years and 4 years) in which you will be asked to bring your baby back to the clinic. The procedures outlined for these visits are listed above. Your baby will be in this follow up study for approximately four years.
Investigators

Principal Investigator
Mark L. Hudak, M.D.
Pediatrics

Sub Investigator
Rana Alissa, M.D.
Pediatrics

Sub Investigator
Neil J. Alviedo, M.D.
Pediatrics

Sub Investigator
Felix Banadera, M.D.
Pediatrics

Sub Investigator
Lily L. Cuevas, M.D.
Pediatrics

Sub Investigator
Rohan A. Dial, M.D., FAAP
Pediatrics

Sub Investigator
William R. Driscoll, D.O.
Pediatrics

Sub Investigator
Ma Ingyinn, M.D.
Pediatrics

Sub Investigator
James J. Kirk, D.O.
Pediatrics

Sub Investigator
Renu Sharma, M.B.B.S. (M.D.)
Pediatrics

Sub Investigator
Lukas H. Tan, M.D.
Pediatrics

Other
Sandra J. Suchomski, M.D.
Pediatrics

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