Conditions: Jaundice, Neonatal Hyperbilirubinemia, Neonatal
Keywords: G6PD deficiency Antibody (ABO) incompatibility Coombs positive ABO/ rhesus factor (RH) incompatibility Intensive phototherapy in neonates
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Participants receive placebo and phototherapy arm 2: Participants receive stannsoporfin (3.0 mg/kg) and phototherapy arm 3: Participants receive stannsoporfin (4.5 mg/kg) and phototherapy

Interventions: intervention 1: Phototherapy intervention 2: Stannsoporfin intervention 3: Placebo
Intervention descriptions: intervention 1: Phototherapy starts within 30 minutes before or after injection intervention 2: Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle) intervention 3: Matching placebo administered by IM injection

Protocol document: