Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

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Brief Title

Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

Official Title

Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus in Preterm infants-a Multicenter Trial

Brief Summary

      The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA)
      treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For
      the purposes of the study infants will be enrolled if they are delivered before 28 weeks
      gestation and have a moderate/large PDA present at 5-7 days after birth.

      The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease
      the time needed for assisted respiratory support, diuretic therapy, and gavage feeding
      assistance, in addition to decreasing the incidence of ductus ligations or need for future
      outpatient cardiology follow-up appointments. The investigators hypothesize that one or more
      of these benefits will occur without an increase in the time taken to achieve full enteral
      feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal
      perforations (SIP).The investigators will be comparing the effectiveness of early
      pharmacologic treatment with a control group of conservatively managed infants who will only
      receive treatment if they meet specific criteria for "rescue treatment".
    

Detailed Description

      Prior studies showed that, if a moderate/large Patent Ductus Arteriosus (PDA) is still
      present at 5 days after birth (among infants delivered at 23 and 0/7 to 25 and 6/7 weeks
      gestation) or at 7 days after birth (among infants delivered at 26 and 0/7 to 27 and 6/7
      weeks gestation), it will persist for at least another 4-12 weeks if it is left untreated.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits)

Secondary Outcome

 Duration of Gavage Feeding Assistance

Condition

Patent Ductus Arteriosus

Intervention

pharmacologic treatment of the PDA

Study Arms / Comparison Groups

 Early treatment
Description:  Infants randomized to the early treatment group will receive "pharmacologic treatment of the PDA" to produce PDA closure. Within 24-36 hr following the last treatment dose an echocardiogram will be obtained to document the degree of ductus closure or patency.
Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.

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

Other

Estimated Enrollment

202

Start Date

December 2013

Completion Date

June 2017

Primary Completion Date

June 2017

Eligibility Criteria

        Inclusion Criteria:

        This will be a prospective randomized, multi-center, controlled trial that will enroll
        infants delivered between 23 & 0/7 - 27 & 6/7 weeks gestation:

          1. infants must be between 5-14 days old (if delivered between 23 and 0/7 - 25 and 6/7
             weeks) or 7-14 days old (if delivered between 26 & 0/7 - 27 & 6/7 weeks) and

          2. have a "moderate size PDA" (defined as a PDA on echocardiogram that has at least one
             of the following criteria: internal ductus diameter ≥1.5 mm/kg (or PDA:LPA ratio
             ≥0.5), ductus flow velocity ≤2.5 m/s or mean pressure gradient across the ductus <8
             mm, LA/Ao ratio ≥1.5, left pulmonary artery diastolic (or mean) flow velocity >0.2 (or
             >0.42) m/sec, respectively, and/or reversed diastolic flow in the descending
             aorta)(13, 68, 69) and

          3. are receiving respiratory support consisting of either mechanical ventilation, nasal
             CPAP, SiPAP, or nasal cannula flow ≥2 L/min.

             -

             Exclusion Criteria:

             prior treatment with indomethacin, ibuprofen, or acetaminophen, contraindications for
             the use of indomethacin, ibuprofen, or acetaminophen (these include: hydrocortisone
             administration within 24 hrs, urine output < 1 ml/kg/h during the preceding 8 h, serum
             creatinine level >1.6 mg/dl, platelet count <50, 000/mm3, abnormal coagulation
             studies, or total bilirubin concentration (in mg/dL) > 8 x weight (in kg)),
             chromosomal anomalies, congenital or acquired gastrointestinal anomalies, prior
             episode of necrotizing enterocolitis or intestinal perforation.

             -
      

Gender

All

Ages

N/A - 14 Days

Accepts Healthy Volunteers

No

Contacts

Ronald Clyman, MD, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT01958320

Organization ID

RC4


Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco


Study Sponsor

Ronald Clyman, MD, Principal Investigator, University of California, San Francisco


Verification Date

November 2018