IV Acetaminophen and Patent Ductus Arteriosus

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Patent ductus arteriosus
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Brief Title

IV Acetaminophen and Patent Ductus Arteriosus

Official Title

The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants

Brief Summary

      This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV
      ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm
      infants.

Study Type

Interventional

Primary Outcome

Rate of PDA Closure

Secondary Outcome

 Change in PDA size

Condition

Patent Ductus Arteriosus

Intervention

Acetaminophen

Study Arms / Comparison Groups

 acetaminophen
Description:  Group of patients randomized to receive acetaminophen to treat their PDA

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

10

Start Date

January 1, 2017

Completion Date

June 30, 2019

Primary Completion Date

June 30, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  preterm infants 23-30 weeks gestation,

          -  PDA requiring treatment

        Exclusion Criteria:

          -  infection,

          -  congenital heart disease,

          -  genetic syndrome,

          -  NEC,

          -  pulmonary hypertension,

          -  hydrops,

          -  intestinal perforation,

          -  grade 3 or 4 IVH,

          -  serum creatinine >1.5,

          -  previous treatment with a COX inhibitor.

Gender

All

Ages

N/A - 2 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03008876

Organization ID

4683

Responsible Party

Principal Investigator

Study Sponsor

Albany Medical College

Study Sponsor

, ,

Verification Date

July 2019