Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

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Brief Title

Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Official Title

Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Brief Summary

      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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Closure of arterial duct - yes / No

Secondary Outcome

 Need for surgical closure of arterial duct

Condition

PDA

Intervention

Paracetamol

Study Arms / Comparison Groups

 No known PDA
Description:  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.

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

19

Start Date

January 1, 2013

Completion Date

December 31, 2018

Primary Completion Date

December 31, 2018

Eligibility Criteria

        Inclusion Criteria:

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

        Exclusion Criteria:

          -  None
      

Gender

All

Ages

N/A - 4 Months

Accepts Healthy Volunteers

No

Contacts

Erez Nadir, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT01755728

Organization ID

77-12-HYMC-CTIL


Responsible Party

Principal Investigator

Study Sponsor

Hillel Yaffe Medical Center


Study Sponsor

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


Verification Date

August 2019