Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004785
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Study of Dexamethasone Vs DexamethasoneMethylprednisolone Vs Placebo for Bronchopulmonary Dysplasia
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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 dexamethasone DM vs DMmethylprednisolone treatment vs placebo initiated within the first month of life on long-term pulmonary and developmental outcomes in premature infants with evolving bronchopulmonary dysplasia
II Compare the toxicities of these treatments III Assess treatment effects on adrenal function
II Compare the toxicities of these treatments III Assess treatment effects on adrenal function
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are randomly assigned to 1 of 3 treatment groups The first group receives intravenous dexamethasone tapered over 42 days
The second group receives daily intravenous dexamethasone for 6 days then intravenous methylprednisolone MePRDL tapered over the next 34 days beginning on day 8 A placebo is given on off MePRDL days
The third group receives an intravenous placebo for 42 days with a tapering schedule beginning day 35
All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 andor 30 as clinically indicated Study drugs are suspended during rescue therapy
The second group receives daily intravenous dexamethasone for 6 days then intravenous methylprednisolone MePRDL tapered over the next 34 days beginning on day 8 A placebo is given on off MePRDL days
The third group receives an intravenous placebo for 42 days with a tapering schedule beginning day 35
All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 andor 30 as clinically indicated Study drugs are suspended during rescue therapy
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 |
|---|---|---|---|
| UIHC-69501 | None | None | None |