Stannsoporfin With Light Therapy for Newborn Babies With Jaundice
Condition: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Intervention: Phototherapy; Stannsoporfin; Placebo
Intervention description: Phototherapy starts within 30 minutes before or after injection; Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle); Matching placebo administered by IM injection
Intervention MeSH terms: Tin mesoporphyrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 1 Hour
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: G6PD deficiency; Antibody (ABO) incompatibility; Coombs positive ABO/ rhesus factor (RH) incompatibility; Intensive phototherapy in neonates

Summary:

      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.
    

Eligibility criteria:

        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