Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Babies may only participate if they meet all the following criteria:
Is a term or late preterm baby
Is at risk for protocol-defined hemolytic disease
Weighs at least 2500 g (5.5 lbs)
Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
Has parents/guardians who are willing to follow light precautions and sign informed consent
You may not be if
Needs medications that may prolong the QT interval
Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
Has an Apgar score of 6 or below at age 5 minutes
Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results
Clareo Health | A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
