Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

August 5, 2019 updated by: Erez Nadir, MD, Hillel Yaffe Medical Center

There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants.

The investigators conducted this open label non randomized and non control study to try to support that report.

Study Overview

Status

Completed

Conditions

Detailed Description

In-uteri, the arterial duct connects between the aorta and the main pulmonary artery, thus bypassing the lungs. Since the high pulmonary pressure and the low systemic pressure, the shunt trough the arterial duct in that time is right to left.

After birth, systemic pressure rises and pulmonary pressure declines. As oxygen saturation rises, and prostaglandin secretion, the arterial duct closes, usually. In preterm infants, the arterial duct may remain open after birth. At this tume the shunt would be left to right, that would cause pulmonary congestion, and systemic hypoperfusion.

Ibuprofen is the treatment of choice for PDA in preterm infants. Yet, ibuprofen is not effective after two weeks of age. Moreover, there are situations that prevent treatment with ibuprofen, such as thrombocytopenia or renal failure. Surgical closure of arterial duct is an alternative treatment, if ibuprofen is contraindicated, or if it fails.

Lastly, there was a report that acetaminophen may have a role in pharmacological closure of PDA in preterm infants.

The investigators conducted this open label non randomized and non control study to try to support that report.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 3

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

      • Hadera, Israel, 38100
        • Neonatal intensive care unit, Hillel Yaffe 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

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm infants with symptomatic PDA who could not be treated with ibuprofen

Exclusion Criteria:

  • None

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No known PDA
For all infants, we do echo cardiogram study only if they are suspected of having PDA, due to sings and symptoms. Hence, we do not do echo cardiogram study to most of the infants.
Active Comparator: Ibuprofen
If there is a PDA, that should be treated, and the infant is less than 2 weeks of age, we use ibuprofen, as this is the gold standard in literature.
Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
Active Comparator: Surgical closure of PDA
Infants with symptomatic PDA, who had to be treated, but could not be treated by ibuprofen, either due to age (> 2 weeks) or due ibuprofen contraindications (thrombocytopenia or renal failure), whose could not be treated by paracetamol (either because of parents' refuse or because they were on nothing per os protocol due to other disease), for whom surgery was the treatment of choice to close the arterial duct.
Open surgery for closure of PDA
Experimental: Paracetamol
Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.
Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
Other Names:
  • Acetaminophen
No Intervention: DA closed spontaneously
Infants with PDA, who did not get any treatment for it, and the duct was closed spontaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure of arterial duct - yes / No
Time Frame: 1 week
Echo-cardiogram that will give exact answer to the question: "was the arterial duct closed"?
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for surgical closure of arterial duct
Time Frame: 1 week
The clinical state of the infant will guide the team to ask the parents and the chest surgeon to surgically close the arterial duct
1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death or deterioration
Time Frame: 1 week
The infant state deteriorates so quickly that it will die, either because of complication of the arterial duct, or because other causes, such as sepsis, metabolic disorder, etc...
1 week

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Erez Nadir, MD, Hillel Yaffe medical center, Hadera, Israel

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)

January 1, 2013

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

December 16, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

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.

Clinical Trials on PDA

Clinical Trials on Ibuprofen

3
Subscribe