Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
It is normal for red blood cells to die, even in newborn babies. The waste from that is
 called bilirubin. The liver clears bilirubin out of the body.

 Some babies are born with illness that makes red blood cells die too fast, so the liver is
 not strong enough to keep up with it.

 The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be
 dangerous if a baby's bilirubin gets too high.

 Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of
 bilirubin.

 This study tests an experimental drug to see if it can help the liver even more, by safely
 cutting down the amount of bilirubin the body is making in the first place.
Participants randomized (1:1:1) to treatment groups will be term or near-term infants with
 isoimmune hemolytic disease or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Inclusion Criteria:

 1. Term and near term infants ≥35 and ≤ 43 weeks gestational age (GA), age 0-48 hours
 with antibody (ABO) or rhesus factor (Rh) incompatibility (anti C, c, D, E or e) who
 are Coombs positive, or age 0-72 hours with G6PD deficiency

 2. Parental or guardian consent

 3. Birth weight ≥ 2500 grams

 4. At or above the age-specific threshold for initiating phototherapy (PT) per the
 American Academy of Pediatrics (AAP) guidelines based on measurement of total serum
 bilirubin (TSB)

 5. Parents agree to observe light precautions for 10 days post treatment

 Exclusion Criteria:

 1. Elevated direct bilirubin ≥2 mg/dL, OR > 20% of the total serum bilirubin

 2. Alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN) and/or
 aspartate aminotransferase (AST) > 3 times ULN

 3. Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the
 ULN

 4. Any other clinically significant abnormalities on screening laboratory evaluation
 [including electrocardiogram (ECG)] that in the opinion of the investigator makes the
 patient unsuitable for the clinical trial

 5. Apgar score ≤6 at age 5 minutes

 6. An unexplained existing rash or skin erythema

 7. Prior exposure to PT

 8. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid
 disease in the mother (maternal Hashimoto's disease is not exclusionary)

 9. Cardio-respiratory distress, defined as a respiratory rate >60 breaths per minute at
 time of enrollment

 10. Any abnormal auditory or ophthalmologic findings on screening physical exam

 11. Treatment or need for treatment in the neonate with medications that are photoreactive
 or may prolong the QT interval (erythromycin ointment for eye prophylaxis is
 permitted), or family history of Long QT syndrome

 12. Known porphyrias or risk factors for porphyrias, including family history

 13. A maternal history of systemic lupus erythematosus

 14. Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding

 15. Maternal current drug or alcohol abuse, or maternal history of drug or alcohol abuse
 that, in the opinion of the Investigator, would not make the patient a suitable
 candidate for participation in the clinical trial

 16. Significant congenital anomalies or infections

 17. Risk of requiring surgery or exposure to operating room (OR) lights in the first 2
 weeks of life

 18. Persistent hypoglycemia (blood glucose <40 mg/dL)

 19. Temperature instability defined as temperature consistently (3 consecutive times) <36
 degrees centigrade (ºC) and/or >37.5 degrees centigrade (ºC) axillary

 20. Use of intravenous immunoglobulin (IVIg) or albumin prior to study drug administration

 21. Post-delivery treatment with medications that are known or suspected to displace
 bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics)

 22. Use of photosensitizing drugs or agents

 23. Unwillingness of parents/guardians to adhere to recommendations regarding light
 precautions

 24. Exposure to any investigational medications or devices after delivery, or
 participation in another clinical trial while participating in this trial

 25. Any other concurrent medical condition, which in the opinion of the Investigator,
 makes the patient unsuitable for the clinical trial