Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hemolysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
It is a normal process in the human body for red blood cells to die, which makes bilirubin.

Bilirubin is cleared away through the liver.

Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice).

This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.

Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin.

This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.

Detailed description:
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.

Arms:
arm 1: Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed. arm 2: Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed. arm 3: Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed. arm 4: Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.

Interventions: intervention 1: Stannsoporfin intervention 2: Placebo intervention 3: PhotoTherapy (as needed)
Intervention descriptions: intervention 1: Stannsoporfin administered as a single IM injection intervention 2: Placebo (sterile saline solution) administered as a single IM injection intervention 3: PT standard care administered as needed, based on bilirubin levels throughout the treatment period

Protocol document: