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
11
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
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03289390
Organization ID
4846
Responsible Party
Principal Investigator
Study Sponsor
Albany Medical College
Study Sponsor
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Verification Date
January 2020