Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217191
Status:
COMPLETED
Last Update Posted:
2006-09-19
First Post:
2005-09-14
Brief Title:
Ibuprofen and Renal Function in Premature Infants
Sponsor:
Maternite Regionale Universitaire
Organization:
Maternite Regionale Universitaire
Study Overview
Official Title:
Ibuprofen and Renal Function in Premature Infants
Status:
COMPLETED
Status Verified Date:
2006-09
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:
Purpose of the study
1 To evaluate renal function maturation within the first month of life in very premature infants
2 To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life
1 To evaluate renal function maturation within the first month of life in very premature infants
2 To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life
Detailed Description:
Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus Several studies showed that Ibuprofen has significantly less side effects than Indomethacin that was used for this indication However experimental studies and few clinical observations suggested that side effects on renal function could occur in very premature infants
Purpose of the study
1 To evaluate renal function maturation within the first month of life in very premature infants
2 To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life
Population
At least 120 infants 27 to 31 weeks gestation will be studied That number will allow to demonstrate a 30 difference in creatinine clearance on day 7 postnatally Careful recording of mother and child history and associated therapies prone to alter renal function should allow to improve the use of this treatment
Purpose of the study
1 To evaluate renal function maturation within the first month of life in very premature infants
2 To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life
Population
At least 120 infants 27 to 31 weeks gestation will be studied That number will allow to demonstrate a 30 difference in creatinine clearance on day 7 postnatally Careful recording of mother and child history and associated therapies prone to alter renal function should allow to improve the use of this treatment
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 |
|---|---|---|---|
| PHRC200417-06 | None | None | None |