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Addition of Acetaminophen in Standard PDA Management

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.

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Intravenous Ibuprofen Drug: Intravenous Ibuprofen + Oral Acetaminophen Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Ibuprofen+Acetaminophen Group
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).
 Drug: Intravenous Ibuprofen + Oral Acetaminophen
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.
Placebo Comparator: Ibuprofen Group
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.
 Drug: Intravenous Ibuprofen
The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
Outcome Measures
Primary Outcome Measures :
  1. Percentage of infants with PDA closure. [ Time Frame: During hospitalization, up to 10 days ]
    Percentage of patients who demonstrated PDA closure.


Eligibility Criteria
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Ages Eligible for Study:   23 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
    2. 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)
    3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)

  • Echocardiographic criteria:

    1. 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
Contacts and Locations

Contacts
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Contact: Sanket D Shah, MD 904-202-4242 Sanket.Shah@jax.ufl.edu

Locations
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United States, Florida
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
Contact: Sanket D Shah, MD    904-202-4242    Sanket.Shah@jax.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Sanket D Shah, MD University of Florida
Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 29, 2020
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		Percentage of infants with PDA closure. [ Time Frame: During hospitalization, up to 10 days ]
Percentage of patients who demonstrated PDA closure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addition of Acetaminophen in Standard PDA Management
Official Title  ICMJE Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Patent Ductus Arteriosus
Intervention  ICMJE
  • Drug: Intravenous Ibuprofen
    The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
  • Drug: Intravenous Ibuprofen + Oral Acetaminophen
    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.
Study Arms  ICMJE
  • Active Comparator: Ibuprofen+Acetaminophen Group
    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).
    Intervention: Drug: Intravenous Ibuprofen + Oral Acetaminophen
  • Placebo Comparator: Ibuprofen Group
    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: Drug: Intravenous 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019) 		230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

    1. Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
    2. 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)
    3. Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)

  • Echocardiographic criteria:

    1. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Weeks to 28 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sanket D Shah, MD 904-202-4242 Sanket.Shah@jax.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026464
Other Study ID Numbers  ICMJE IRB201901829 -A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanket D Shah, MD University of Florida
PRS Account University of Florida
Verification Date July 2020

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

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