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

May 27, 2020checkorphan

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Patent ductus arteriosus

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Brief Title

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

Official Title

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

Brief Summary

      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 Type

Observational

Primary Outcome

Rate of PDA closure

Condition

Patent Ductus Arteriosus

Intervention

Acetaminophen

Study Arms / Comparison Groups

 Acetaminophen to close PDA

Description:  Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen

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

Start Date

August 1, 2017

Completion Date

June 30, 2019

Primary Completion Date

June 30, 2019

Eligibility Criteria

        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

Gender

All

Ages

23 Weeks - 30 Weeks

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03289390

Organization ID

Responsible Party

Principal Investigator

Study Sponsor

Albany Medical College

Study Sponsor

, ,

Verification Date

January 2020