Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004381
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Compare the efficacy of preventive vs therapeutic tin mesoporphyrin in direct Coombs test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in Greece
II Assess the safety of tin mesoporphyrin in high-risk newborns
II Assess the safety of tin mesoporphyrin in high-risk newborns
Detailed Description:
PROTOCOL OUTLINE Patients are stratified by gestational age and sex and randomly assigned in pairs per stratum
One group receives a preventive dose of tin mesoporphyrin Another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration
Patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated
One group receives a preventive dose of tin mesoporphyrin Another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration
Patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RUH-0330795A | None | None | None |