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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

Tracking Information
First Submitted Date  ICMJE December 30, 2016
First Posted Date  ICMJE January 4, 2017
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
Rate of PDA Closure [ Time Frame: 3 days ]
PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Acetaminophen and Patent Ductus Arteriosus
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patent Ductus Arteriosus
Intervention  ICMJE
  • Drug: Acetaminophen
    infants receive acetaminophen for treatment of their PDA
    Other Name: tylenol
  • Drug: Ibuprofen
    infants receive ibuprofen, standard of care in our unit, for treatment of a PDA
Study Arms  ICMJE
  • Experimental: acetaminophen
    Group of patients randomized to receive acetaminophen to treat their PDA
    Intervention: Drug: Acetaminophen
  • Active Comparator: ibuprofen
    Group of patients randomized to receive ibuprofen to treat their PDA
    Intervention: Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2017)
40
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03008876
Other Study ID Numbers  ICMJE 4683
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kate Tauber, Albany Medical College
Study Sponsor  ICMJE Albany Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Albany Medical College
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP