Back to resultsAddition of Acetaminophen in Standard PDA Management
Primary Purpose
Patent Ductus Arteriosus
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intravenous Ibuprofen
Intravenous Ibuprofen + Oral Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus
Eligibility Criteria
Inclusion Criteria:
- Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams
Hemodynamically significant PDA as defined by any of the following:
- Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
- Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
- Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
Echocardiographic criteria:
- Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5
Exclusion Criteria:
- No enteral feedings
- PDA-dependent congenital heart disease
- Prior treatment with prophylactic indomethacin
- Prior PDA treatment with any medications
- Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
- Abnormal liver enzymes (ALT > 60 IU/L and AST > 60 IU/L)
- Platelets count < 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
- Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
- Prior enrollment to other interventional clinical study where PDA is an outcome variable
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ibuprofen+Acetaminophen Group
Ibuprofen Group
Arm Description
Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses).
Infants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone.
Outcomes
Primary Outcome Measures
Percentage of infants with PDA closure.
Percentage of patients who demonstrated PDA closure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04026464
Brief Title
Addition of Acetaminophen in Standard PDA Management
Official Title
Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain funding to support this project
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen+Acetaminophen Group
Arm Type
Active Comparator
Arm Description
Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses).
Arm Title
Ibuprofen Group
Arm Type
Placebo Comparator
Arm Description
Infants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone.
Intervention Type
Drug
Intervention Name(s)
Intravenous Ibuprofen
Intervention Description
The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
Intervention Type
Drug
Intervention Name(s)
Intravenous Ibuprofen + Oral Acetaminophen
Intervention Description
The combined treatment group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently and will in addition receive 15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses.
Primary Outcome Measure Information:
Title
Percentage of infants with PDA closure.
Description
Percentage of patients who demonstrated PDA closure.
Time Frame
During hospitalization, up to 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams
Hemodynamically significant PDA as defined by any of the following:
Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
Echocardiographic criteria:
Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5
Exclusion Criteria:
No enteral feedings
PDA-dependent congenital heart disease
Prior treatment with prophylactic indomethacin
Prior PDA treatment with any medications
Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
Abnormal liver enzymes (ALT > 60 IU/L and AST > 60 IU/L)
Platelets count < 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
Prior enrollment to other interventional clinical study where PDA is an outcome variable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanket D Shah, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Addition of Acetaminophen in Standard PDA Management
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