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IV Acetaminophen and Patent Ductus Arteriosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03008876
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Kate Tauber, Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Acetaminophen Drug: Ibuprofen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019


Arm Intervention/treatment
Experimental: acetaminophen
Group of patients randomized to receive acetaminophen to treat their PDA
Drug: Acetaminophen
infants receive acetaminophen for treatment of their PDA
Other Name: tylenol

Active Comparator: ibuprofen
Group of patients randomized to receive ibuprofen to treat their PDA
Drug: Ibuprofen
infants receive ibuprofen, standard of care in our unit, for treatment of a PDA




Primary Outcome Measures :
  1. Rate of PDA Closure [ Time Frame: 3 days ]
    PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.


Secondary Outcome Measures :
  1. Change in PDA size [ Time Frame: 3 days ]
    Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008876


Locations
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United States, New York
Albany Medical Center Neonatal Intesive Care Unit
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College

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Responsible Party: Kate Tauber, Assistant Professor, Albany Medical College
ClinicalTrials.gov Identifier: NCT03008876    
Other Study ID Numbers: 4683
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kate Tauber, Albany Medical College:
neonate
acetaminophen
Additional relevant MeSH terms:
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Acetaminophen
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action