An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants

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Brief Title

An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants

Official Title

An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants- A Randomized Pilot Study

Brief Summary

      A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary
      hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular
      bleeding. Indomethacin is the first line of treatment for PDA. Failure of ductal closure with
      the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate
      in infants weighing < 1000 gm. PDA ligation is associated with early postoperative
      hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants.
      The use of escalating doses of Indomethacin in the treatment of persistent PDA was found to
      be safe and decreased the need for PDA ligation without adverse effects in one observational
      study.We hypothesize that the use of an escalated dose of intravenous indomethacin will
      result in an increase in the probability of survival without need for surgical ligation of
      PDA as compared to a standard dose indomethacin in newborn infants < 29 weeks of gestational
      age with persistent PDA.
    

Detailed Description

      This study is a randomized control trial.Those eligible infants will be randomized to either
      a Standard Dose group or to Escalating Dose indomethacin group after obtaining parental
      consent. The infants randomized to the standard dose group will receive indomethacin (0.1
      mg/kg) at 24 hr intervals for 5 days. Escalating Dose group infants will receive indomethacin
      (0.2 mg/kg/dose) at 12 hr intervals for 2 doses, followed by indomethacin (0.3 mg/kg/dose) at
      12 hr interval for 2 doses, then Indomethacin (0.4 mg/kg/dose) at 12 hr interval for 2 doses,
      increased to indomethacin (0.5 mg/kg/dose) at 12 hour interval for 2 doses and finally
      indomethacin 0.6 mg/kg/dose at 12 hourly interval for 2 doses. To keep the study blinded, the
      standard group will receive 5 extra doses of normal saline infusion of similar volume at 12
      hrly intervals between the indomethacin schedules to match the Escalating dose Indomethacin
      Schedule. Daily Echo will be performed and if the Echo showed closure of PDA after 3 days of
      assigned treatment, no further indomethacin will be given in both the groups.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Survival without PDA ligation at discharge

Secondary Outcome

 PDA closure rate

Condition

Patent Ductus Arteriosus

Intervention

Indomethacin

Study Arms / Comparison Groups

 Standard dose group
Description:  The infants randomized to the standard dose group will receive indomethacin (0.1 mg/kg) at 24 hr intervals for 5 days. These infants will also receive 5 extra doses of normal saline infusion of similar volume at 12 hrly intervals between the indomethacin schedules to match the Escalating dose Indomethacin Schedule

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

9

Start Date

August 2008

Completion Date

January 2013

Primary Completion Date

January 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Preterm infants with gestational age < 29 weeks and/or birth weight < 1251gm

          -  Presence of PDA after completion of first course of indomethacin

        Exclusion Criteria:

          -  Infants with PDA dependent congenital heart disease

          -  Chromosomal or major congenital anomalies

          -  Infants in whom use of indomethacin is contraindicated.(i.e.infants with acute renal
             failure,necrotizing enterocolitis,severe thrombocytopenia (platelet count < 60,000/
             mm3) and evidence of clinical bleeding (pulmonary bleeding, severe intraventricular
             bleeding grade 3&4)
      

Gender

All

Ages

N/A - 4 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Amuchou S Soraisham, MD, DM, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00750581

Organization ID

RT734510


Responsible Party

Principal Investigator

Study Sponsor

University of Calgary


Study Sponsor

Amuchou S Soraisham, MD, DM, Principal Investigator, University of Calgary


Verification Date

August 2016