Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00485160
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2007-06-11
Brief Title:
Ibuprofen vs Continuous Indomethacin in the Treatment of PDA
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
Comparison of Intravenous Ibuprofen vs Continuous Indomethacin in the Treatment of Patent Ductus Arteriosus
Status:
COMPLETED
Status Verified Date:
2007-06
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:
The purpose of this study is to determine whether closure of the PDA in premature neonates using IV ibuprofen vs continuous IV indomethacin has different side effects eg effects on renal function on blood flow velocity in the superior mesenteric artery the anterior cerebral artery and the renal artery
Detailed Description:
Despite the fact that ibuprofen appears to minimize the renal side effects seen following bolus indomethacin other concerns regarding both short and long-term safety remain Indomethacin on the other hand has been used to treat premature neonates for many years Other than transient vasoconstrictive effects no significant toxicity has been noted Thus if we were to be able to eliminate the differential renal effects indomethacin would remain for many the therapy of choice for the premature neonate with a persistent PDA We hypothesized that continuous administration of indomethacin would provide this option Ibuprofen therapy has not to date been compared with indomethacin administered by continuous infusion Hence in the current study we attempted to determine whether continuous indomethacin administration could potentially offer the same advantages as ibuprofen in treating PDA specifically in terms of mitigation of renal side effects Specifically our primary objective was to show no differences in urine output andor in serum creatinine between the treatment groups As a secondary objective we aimed to show no other potentially vascular-mediated clinical differences eg Necrotizing enterocolitis NEC intraventricular hemorrhage IVH retinopathy of prematurity ROP and on bilirubin albumin binding between the groups
B-type natriuretic peptide BNP is released by ventricular myocytes in response to ventricular volume load It in turn mediates vasodilation natriuresis and diuresis Serum BNP levels have been shown to be clinically useful in differentiating between respiratory and cardiac disease in monitoring heart failure therapies and in serving as early diagnostic biomarkers of ductal patency in premature neonates As secondary objectives we intend to determine whether a decrease in BNP levels would be an equally reliable indicator of therapeutic efficacy in infants treated with ibuprofen as with indomethacinIn addition we will look at comparative effects on other vascular beds which might mediate long term side effects described above
B-type natriuretic peptide BNP is released by ventricular myocytes in response to ventricular volume load It in turn mediates vasodilation natriuresis and diuresis Serum BNP levels have been shown to be clinically useful in differentiating between respiratory and cardiac disease in monitoring heart failure therapies and in serving as early diagnostic biomarkers of ductal patency in premature neonates As secondary objectives we intend to determine whether a decrease in BNP levels would be an equally reliable indicator of therapeutic efficacy in infants treated with ibuprofen as with indomethacinIn addition we will look at comparative effects on other vascular beds which might mediate long term side effects described above
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