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Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure

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. Identifier: NCT00833365
Recruitment Status : Terminated (Study drug not available)
First Posted : February 2, 2009
Results First Posted : July 4, 2016
Last Update Posted : July 4, 2016
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Utah

Brief Summary:
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.

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

Detailed Description:
Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of <96 hrs old and >96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction
Study Start Date : January 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Active Comparator: Early treatment
Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
Drug: Ibuprofen
Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose
Other Name: NeoProfen

Active Comparator: Late treatment
Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
Drug: Ibuprofen
Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
Other Name: NeoProfen

Primary Outcome Measures :
  1. Number of PDA Closures Related to Treatment With Ibuprofen [ Time Frame: Within 48 hrs of ibuprofen round ]
    Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.

Secondary Outcome Measures :
  1. Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration [ Time Frame: 1 and 6 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 96 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Birth weight less than 1200gm
  • Less than 28 weeks gestational age
  • Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

Exclusion Criteria:

  • Active Bleeding
  • Currently being treated for Persistent Pulmonary Hypertension (PPHN)
  • Cardiac anomalies
  • Chromosomal abnormalities
  • Endocrine, metabolic, renal, or hepatic disorders

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 identifier (NCT number): NCT00833365

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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
H. Lundbeck A/S
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Principal Investigator: Gary Chan, MD University of Utah

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Responsible Party: University of Utah Identifier: NCT00833365     History of Changes
Other Study ID Numbers: 31394
First Posted: February 2, 2009    Key Record Dates
Results First Posted: July 4, 2016
Last Update Posted: July 4, 2016
Last Verified: December 2014
Keywords provided by University of Utah:
premature infants
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action