Addition of Acetaminophen in Standard PDA Management

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Patent ductus arteriosus
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Brief Title

Addition of Acetaminophen in Standard PDA Management

Official Title

Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial

Brief Summary

      Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA
      varies among neonatologist. The investigators are conducting a randomized controlled trial to
      determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a
      first treatment course.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Percentage of infants with PDA closure.

Condition

Patent Ductus Arteriosus

Intervention

Intravenous Ibuprofen

Study Arms / Comparison Groups

 Ibuprofen+Acetaminophen Group
Description:  Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses).

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

230

Start Date

April 2021

Completion Date

March 2023

Primary Completion Date

March 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams

          -  Hemodynamically significant PDA as defined by any of the following:

               1. Increased ventilator or oxygen support attributed by the clinician to be due to
                  increased left-right shunting through the PDA

               2. Hypotension and/or widening pulse pressure requiring continuous dopamine infusion
                  (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below
                  the infants' post menstrual age)

               3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest
                  radiograph or hepatomegaly on physical examination)

          -  Echocardiographic criteria:

               1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery
                  > 0.5

        Exclusion Criteria:

          -  No enteral feedings

          -  PDA-dependent congenital heart disease

          -  Prior treatment with prophylactic indomethacin

          -  Prior PDA treatment with any medications

          -  Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal
             perforation

          -  Abnormal liver enzymes (ALT > 60 IU/L and AST > 60 IU/L)

          -  Platelets count < 50,000 /μl; and / or active intracranial, gastrointestinal, or other
             bleeding

          -  Major congenital anomalies such as neural tube defect, known or suspected chromosomal
             abnormality, and gastrointestinal defect

          -  Prior enrollment to other interventional clinical study where PDA is an outcome
             variable

Gender

All

Ages

23 Weeks - 28 Weeks

Accepts Healthy Volunteers

No

Contacts

Sanket D Shah, MD, 904-202-4242, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04026464

Organization ID

IRB201901829 -A

Responsible Party

Sponsor

Study Sponsor

University of Florida

Study Sponsor

Sanket D Shah, MD, Principal Investigator, University of Florida

Verification Date

July 2020