Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA

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Brief Title

Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA

Official Title

Comparison of Intravenous Ibuprofen vs. Continuous Indomethacin in the Treatment of Patent Ductus Arteriosus

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 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

To show no differences in urine output and/or in serum creatinine between the treatment groups

Secondary Outcome

 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.

Condition

Patent Ductus Arteriosus

Intervention

Continuous indomethacin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

70

Start Date

February 2002

Completion Date

September 2006


Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 3 Weeks

Accepts Healthy Volunteers

No

Contacts

Cathy Hammerman, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT00485160

Organization ID

chammerman2



Study Sponsor

Shaare Zedek Medical Center


Study Sponsor

Cathy Hammerman, MD, Principal Investigator, Shaare Zedek Medical Center


Verification Date

June 2007