Back to resultsIV Acetaminophen and Patent Ductus Arteriosus
Primary Purpose
Patent Ductus Arteriosus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring neonate, acetaminophen
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.
Sites / Locations
- Albany Medical Center Neonatal Intesive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
acetaminophen
ibuprofen
Arm Description
Group of patients randomized to receive acetaminophen to treat their PDA
Group of patients randomized to receive ibuprofen to treat their PDA
Outcomes
Primary Outcome Measures
Rate of PDA Closure
PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
Secondary Outcome Measures
Change in PDA size
Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03008876
Brief Title
IV Acetaminophen and Patent Ductus Arteriosus
Official Title
The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
neonate, acetaminophen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acetaminophen
Arm Type
Experimental
Arm Description
Group of patients randomized to receive acetaminophen to treat their PDA
Arm Title
ibuprofen
Arm Type
Active Comparator
Arm Description
Group of patients randomized to receive ibuprofen to treat their PDA
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
tylenol
Intervention Description
infants receive acetaminophen for treatment of their PDA
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
infants receive ibuprofen, standard of care in our unit, for treatment of a PDA
Primary Outcome Measure Information:
Title
Rate of PDA Closure
Description
PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Change in PDA size
Description
Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Albany Medical Center Neonatal Intesive Care Unit
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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IV Acetaminophen and Patent Ductus Arteriosus
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