Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Study drug not available)
H. Lundbeck A/S
Information provided by (Responsible Party):
University of Utah Identifier:
First received: January 29, 2009
Last updated: May 24, 2016
Last verified: December 2014
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 Intervention
Patent Ductus Arteriosus
Drug: Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Number of PDA Closures Related to Treatment With Ibuprofen [ Time Frame: Within 48 hrs of ibuprofen round ] [ Designated as safety issue: No ]
    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:
  • Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration [ Time Frame: 1 and 6 hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   up to 96 Hours   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00833365

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

Responsible Party: University of Utah Identifier: NCT00833365     History of Changes
Other Study ID Numbers: 31394 
Study First Received: January 29, 2009
Results First Received: May 1, 2015
Last Updated: May 24, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
premature infants

Additional relevant MeSH terms:
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 processed this record on October 21, 2016