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Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485160
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : July 21, 2011
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Continuous indomethacin Drug: ibuprofen Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Intravenous Ibuprofen vs. Continuous Indomethacin in the Treatment of Patent Ductus Arteriosus
Study Start Date : February 2002
Actual Study Completion Date : September 2006

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485160

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Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center

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Responsible Party: Cathy Hammerman, Shaare Zedek Medical Center Identifier: NCT00485160     History of Changes
Other Study ID Numbers: chammerman2
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: June 2007
Keywords provided by Shaare Zedek Medical Center:
Patent Ductus Arteriosus
Renal effects
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents