Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189007
Status:
UNKNOWN
Last Update Posted:
2012-03-29
First Post:
2005-09-11
Brief Title:
Antenatal Allopurinol During Fetal Hypoxia
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Does Antenatal Allopurinol Administration Reduce Post-hypoxic-ischemic Reperfusion Damage During Fetal Hypoxia in the Newborn
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
A former study submitted in 32 severely asphyxiated infants participating in a randomized double blind study in which early postnatal allopurinol or a placebo within 4 hours after birth was administered to reduce free radical formation and consequently reperfusionreoxygenation injury to the newborn brain showed an unaltered high mortality and no clinically relevant improvement in morbidity in infants treated with allopurinol It was hypothesized that postnatal allopurinol treatment started too late to reduce reperfusion-induced free radical surge and that initiating allopurinol treatment of the fetus with imminent hypoxia already via the mother during labor will be more effective to reduce free radical-induced post-asphyxial brain damage
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL2651600009 | OTHER | The Central Committee on Research Involving Human Subjects CCMO | None |
| ALLO-trial | OTHER | None | None |
| 2006-005796-18 | EUDRACT_NUMBER | None | None |
| 170991001 | OTHER_GRANT | None | None |
| NTR-1383 | REGISTRY | None | None |