IV Acetaminophen and Patent Ductus Arteriosus

July 5, 2019 updated by: Kate Tauber, Albany Medical College

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center Neonatal Intesive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: acetaminophen
Group of patients randomized to receive acetaminophen to treat their PDA
Drug: Acetaminophen
infants receive acetaminophen for treatment of their PDA
Other Names:
  • tylenol
Active Comparator: ibuprofen
Group of patients randomized to receive ibuprofen to treat their PDA
Drug: Ibuprofen
infants receive ibuprofen, standard of care in our unit, for treatment of a PDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of PDA Closure
Time Frame: 3 days
PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PDA size
Time Frame: 3 days
Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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