Compassionate Use of Stanate (TM) [Stannsoporfin]

Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria:

1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
2. the infant requires an exchange transfusion; and
3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.

• Term or near term neonate
• Elevated serum bilirubin
• Failing phototherapy
• Requires exchange transfusion
• Family refuses exchange transfusion on religious grounds