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Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA

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ClinicalTrials.gov Identifier: NCT00485160
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

June 11, 2007
June 12, 2007
July 21, 2011
February 2002
Not Provided
To show no differences in urine output and/or in serum creatinine between the treatment groups [ Time Frame: Up to one day after completion of therapy ]
Same as current
Complete list of historical versions of study NCT00485160 on ClinicalTrials.gov Archive Site
To show no other clinical differences, eg. NEC, IVH or ROP between the groups; to study doppler flow velocities to these areas; to correlate with BNP levels. [ Time Frame: Until end of primary hospitalization ]
Same as current
Not Provided
Not Provided
 
Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA
Comparison of Intravenous Ibuprofen vs. Continuous Indomethacin in the Treatment of Patent Ductus Arteriosus
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.

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 and/or 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 indomethacin.In addition we will look at comparative effects on other vascular beds which might mediate long term side effects described above.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Patent Ductus Arteriosus
  • Drug: Continuous indomethacin
  • Drug: ibuprofen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
65
September 2006
Not Provided

Inclusion Criteria:

  • < 1500 gm birth weight with PDA confirmed by echocardiography

Exclusion Criteria:

  • Additional congenital heart lesions
  • Significant congenital malformations
  • Documented infection
  • Thrombocytopenia (<60,000)
  • IVH grade 4
Sexes Eligible for Study: All
up to 3 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00485160
chammerman2
No
Not Provided
Not Provided
Cathy Hammerman, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center
Shaare Zedek Medical Center
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP