Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

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Brief Title

Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

Official Title

Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)

Brief Summary

      This is a pilot study to collect preliminary data for a larger, multicenter clinical trial
      proposal. The study will examine two strategies commonly used to treat preterm infants
      diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term
      infants, but in many preterm infants, it remains open (patent). A PDA may present a
      complication for a number of short-term problems faced by preterm infants. Longer-term issues
      include the development of pulmonary hypertension and changes in the size and performance of
      the heart. There is ongoing debate as to whether or not the PDA requires intervention.
    

Detailed Description

      Preterm infants diagnosed with a hemodynamically-significant patent ductus arteriosus (HSPDA)
      will be included. Specific criteria will be followed to determine if a patent ductus
      arteriosus (PDA) is "hemodynamically significant". Infants will be randomized to two
      different approaches for management of the PDA. The first will be catheter-based closure
      (intervention) and the second will be conservative management (non-intervention). Both
      procedures are standard practice at many institutions, including Nationwide Children's
      Hospital. Infants randomized to receive intervention will undergo a procedure in which a
      catheter is used to place an FDA-approved device within the PDA, to close it (like a plug).
      Infants randomized to the conservative management (non-intervention) group will be permitted
      time to see if the PDA closes on its own, naturally. However, if the PDA remains open and
      intervention is deemed medically necessary, they will also undergo the catheter closure
      procedure.
    


Study Type

Interventional


Primary Outcome

Change in ventilatory support required

Secondary Outcome

 Need for catheter-based closure (applies to Conservative management group only)

Condition

Patent Ductus Arteriosus

Intervention

Cather closure of patent ductus arteriosus (PDA)

Study Arms / Comparison Groups

 Catheter-closure of PDA
Description:  Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).

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

Device

Estimated Enrollment

20

Start Date

December 4, 2019

Completion Date

July 31, 2020

Primary Completion Date

July 31, 2020

Eligibility Criteria

        Maximum age (above) indicates qualifying / eligibility criteria. Participating infants will
        be followed until they reach 36 weeks corrected gestational age OR are discharged from the
        hospital, whichever comes first.

        Inclusion Criteria:

          -  Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent
             ductus arteriosus (PDA) at 2 - 4 weeks of age.

          -  Body weight greater than or equal to 700 grams

        Exclusion Criteria:

          -  Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities

          -  Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal
             defects (ex. Tetrology of Fallot, Single ventricle physiology)

          -  Body weight less than 700 grams
      

Gender

All

Ages

N/A - 28 Days

Accepts Healthy Volunteers

No

Contacts

Carl H Backes, MD, 614-355-6729, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03982342

Organization ID

STUDY00000295


Responsible Party

Principal Investigator

Study Sponsor

Nationwide Children's Hospital

Collaborators

 University of Tennessee Health Science Center

Study Sponsor

Carl H Backes, MD, Principal Investigator, Nationwide Children's Hospital


Verification Date

March 2020