Clinical trials: Neonatal Hyperbilirubinemia
Newborn Jaundice
Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm
Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia.
- Trial name
- Bili-PrediX1 (NCT05121311)
- Testing
- NeoprediX B1 algorithm
- Where
- 2 sites in Germany
- Volunteers
- 455 people
- Sponsor
- NeoPredix AG
Hyperbilirubinemia, Neonatal
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat…
- Trial name
- JASMINE_205 (NCT02000830)
- Testing
- Stannsoporfin
- Volunteers
- 68 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
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.
- Trial name
- JASMINE_204 (NCT01887327)
- Testing
- Phototherapy, Stannsoporfin
- Where
- 18 sites in United States
- Volunteers
- 91 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Hyperbilirubinemia, Neonatal
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
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.
- Trial name
- NCT00850993
- Testing
- Stannsoporfin, PhotoTherapy (as needed)
- Where
- 23 sites in United States, Poland and 2 more
- Volunteers
- 58 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Nutritional and Metabolic Diseases
Efficacy and Safety of Stannsoporfin in Neonates
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the…
- Trial name
- NCT02685137
- Testing
- stannsoporfin
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Neonatal Jaundice, Hyperbilirubinemia
Compassionate Use of Stanate (TM) [Stannsoporfin]
The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] available to infants who meet the following criteria: 1.
- Trial name
- NCT00076960
- Testing
- Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
- Where
- United States
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Jaundice, Neonatal Hyperbilirubinemia
Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study.
- Trial name
- NCT02033096
- Testing
- Stannsoporfin, Phototherapy (as needed)
- Volunteers
- 42 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Hyperbilirubinemia, Neonatal Jaundice
Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and as part of standard of care all hospitalized newborns are routinely monitored for the development of high bilirubin or jaundice every…
- Trial name
- NCT02774434
- Testing
- JM-105
- Where
- 3 sites in Canada
- Volunteers
- 464 people
- Sponsor
- Draeger Medical Systems, Inc.