Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at

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Brief Title

Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus

Official Title

Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus

Brief Summary

      The purpose of this study is to examine if a higher dose of indomethacin will increase the
      rate of ductus arteriosus closure in extremely premature infants without increasing the side
      effects. The long term objective is to find the optimal dosing of indomethacin for permanent
      closure of the Ductus and prevent the morbidity related to PDA and the complications of
      surgical ligation.
    

Detailed Description

      This study is a Phase II randomized, masked, controlled trial that compares the current
      standard dose of indomethacin to a higher dose for the closure of PDA in premature infants
      less than 28 weeks of gestation.

      Neonates (<28 weeks gestation) who are started on indomethacin treatment (with an initial
      3-dose course: 0.2, 0.1, and 0.1 mg/kg of indomethacin) within the first 96 hr after birth
      will be eligible for this trial if they continue to have Doppler evidence of ductus patency
      before the third dose of indomethacin. This group of infants have greater than 65% chance of
      developing symptomatic PDA and surgical ligation even after our standard extended course of
      indomethacin. Those infants who do not fit the exclusion criteria will be randomized to
      either a Standard Dose group or to a Higher Dose group after obtaining consent. The infants
      randomized to the standard group will receive a 4th, 5th, and 6th dose of indomethacin (0.1
      mg/kg) at 24 hr intervals (starting at 24 hr after the 3rd dose). The Higher Dose group
      infants delivered between 26-27 weeks gestation will receive a 4th, 5th, 6th, 7th, 8th and
      9th dose of indomethacin (0.1mg/kg) at 12 hr intervals (starting 12 hr after the 3rd dose).
      The Higher Dose group infants between 24-25 weeks gestation will receive a 4th, 5th, 6th,
      7th, 8th and 9th dose of indomethacin (0.25mg/kg) at 12 hour intervals (starting 12 hr after
      the 3rd dose). To keep the study blinded, the standard group will receive 3 extra doses of
      saline to match the 3 additional doses given to the higher dose group.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The incidence of ductus closure, as determined by echocardiography, following the last dose of study drug

Secondary Outcome

 Altered renal function during treatment

Condition

Patent Ductus Arteriosus

Intervention

indomethacin (two different dosing regimens)


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

100

Start Date

August 2003

Completion Date

July 2006

Primary Completion Date

July 2006

Eligibility Criteria

        Inclusion Criteria:

          1. Newborn infants of less than 28 weeks gestational age who are treated with
             indomethacin during the first 48 hours after birth

          2. Presence of patent ductus arteriosus (PDA) by Doppler echocardiography between the
             second and third dose of indomethacin.

          3. Creatinine ≤1.8 mg/dl

          4. Platelets ≥ 50,000

        Exclusion Criteria:

          1. Chromosomal disorders.

          2. Major congenital anomalies.

          3. Contraindications for indomethacin

               1. Necrotizing enterocolitis, by clinical or radiological evidence

               2. Evidence of bleeding diathesis as evidenced by pulmonary hemorrhage, persistent
                  oozing from puncture sites, grossly bloody stool (Note: Infants with an
                  intracranial hemorrhage can be enrolled in this study).
      

Gender

All

Ages

N/A - 48 Hours

Accepts Healthy Volunteers

No

Contacts

Ronald Clyman, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00187447

Organization ID

RC1



Study Sponsor

University of California, San Francisco


Study Sponsor

Ronald Clyman, M.D., Principal Investigator, University of California, San Francisco


Verification Date

September 2005