Hyperbilirubinemia Clinical Trial
OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special
blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece.
II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy
without adverse effects in these newborns.
PROTOCOL OUTLINE: Patients are randomly assigned to a clinical group within 96 hours of
birth. Patients are stratified by gestational age, clinical status, and age at treatment.
One group receives tin mesoporphyrin. Patients are crossed to phototherapy if the plasma
bilirubin concentration reaches the treatment threshold.
The second group receives phototherapy with Special Blue fluorescent lamps for at least 24
hours. Patients receive a second phototherapy course if the plasma bilirubin concentration
reaches the treatment threshold within 24 hours of the first course.
;
Allocation: Randomized, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00360204 -
Improving Health Outcomes for New Mothers and Babies
|
Phase 3 | |
| Completed |
NCT00383318 -
Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia
|
N/A | |
| Completed |
NCT00115544 -
Safety and Pharmacology of Stanate
|
Phase 2 | |
| Completed |
NCT01622699 -
Implementation of a Transcutaneous Bilirubinometer
|
N/A | |
| Terminated |
NCT00741117 -
Conjugated Hyperbilirubinemia and Pulse Oximetry
|
N/A | |
| Completed |
NCT00288600 -
Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
|
Phase 4 | |
| Completed |
NCT02774434 -
Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
|
N/A | |
| Completed |
NCT01550627 -
Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
|
Phase 0 | |
| Completed |
NCT00653874 -
Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates
|
Phase 3 | |
| Recruiting |
NCT03564678 -
Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Recruiting |
NCT04897113 -
Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old
|
N/A | |
| Recruiting |
NCT01944696 -
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
|
N/A | |
| Completed |
NCT00635375 -
Comparative Study of Phototherapy for Hyperbilirubinemia
|
N/A | |
| Completed |
NCT03195998 -
Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
|
||
| Terminated |
NCT02685189 -
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
|
||
| Completed |
NCT02446951 -
Implementation of a Clinical Decision Rule for Treatment of Neonatal Jaundice in the Emergency Department
|
||
| Terminated |
NCT01136577 -
Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn
|
N/A | |
| Completed |
NCT04271098 -
The Investigation of the Causes of Hepatic Dysfunction in the Postoperative Period During Open-heart Surgeries
|
||
| Completed |
NCT02691156 -
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
|
||
| Completed |
NCT00004381 -
Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
|
Phase 2 |