Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

January 8, 2020 updated by: Ronnelle King, Albany Medical College
This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

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

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

5 months to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature infants born between 23 0/7 weeks to 29 6/7 weeks gestational age.

Description

Inclusion Criteria:

  • Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.

Exclusion Criteria:

  • Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST> 150 U/L, ALT>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acetaminophen to close PDA
Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen
Drug: Acetaminophen
Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.

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
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2017

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (ACTUAL)

September 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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