Brief Title
IV Acetaminophen and Patent Ductus Arteriosus
Official Title
The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants
Brief Summary
This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.
Study Type
Interventional
Primary Outcome
Rate of PDA Closure
Secondary Outcome
Change in PDA size
Condition
Patent Ductus Arteriosus
Intervention
Acetaminophen
Study Arms / Comparison Groups
acetaminophen
Description: Group of patients randomized to receive acetaminophen to treat their PDA
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
10
Start Date
January 1, 2017
Completion Date
June 30, 2019
Primary Completion Date
June 30, 2019
Eligibility Criteria
Inclusion Criteria: - preterm infants 23-30 weeks gestation, - PDA requiring treatment Exclusion Criteria: - infection, - congenital heart disease, - genetic syndrome, - NEC, - pulmonary hypertension, - hydrops, - intestinal perforation, - grade 3 or 4 IVH, - serum creatinine >1.5, - previous treatment with a COX inhibitor.
Gender
All
Ages
N/A - 2 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03008876
Organization ID
4683
Responsible Party
Principal Investigator
Study Sponsor
Albany Medical College
Study Sponsor
, ,
Verification Date
July 2019