Jaundice, Neonatal Clinical Trial
Official title:
A Phase 2b Multicenter, Single Dose, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00735319 -
Transcutaneous Bilirubinometers in the Community
|
N/A | |
Completed |
NCT00114543 -
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
|
Phase 3 | |
Withdrawn |
NCT04021927 -
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
|
N/A | |
Completed |
NCT04632888 -
The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy
|
N/A | |
Not yet recruiting |
NCT04527536 -
Research of Diagnostic Value for BMJ Infants
|
||
Suspended |
NCT03741803 -
Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice
|
N/A | |
Completed |
NCT05650463 -
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
|
N/A | |
Terminated |
NCT05623566 -
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
|
N/A | |
Completed |
NCT02612727 -
Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates
|
N/A | |
Completed |
NCT01434810 -
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
|
N/A | |
Completed |
NCT03184948 -
Understanding Neonatal Jaundice in Rwanda
|
N/A | |
Completed |
NCT03942757 -
BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
|
||
Not yet recruiting |
NCT05806684 -
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
|
||
Completed |
NCT06372093 -
Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana
|
N/A | |
Completed |
NCT03569254 -
Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice
|
N/A | |
Completed |
NCT03570775 -
Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice
|
N/A | |
Completed |
NCT05625880 -
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population
|
N/A | |
Completed |
NCT01169740 -
Transcutaneous Measurement of Jaundice in the Newborn
|
N/A | |
Not yet recruiting |
NCT06449508 -
The Effectiveness of Probiotics in Neonatal Jaundice
|
Phase 1/Phase 2 | |
Completed |
NCT05623553 -
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
|
N/A |