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Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01261117
First Posted: December 16, 2010
Last Update Posted: August 9, 2011
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.
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
  Purpose
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.

Condition Intervention
Patent Ductus Arteriosus Drug: oral ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Oral Versus Intravenous Ibuprofen Treatment

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575 [ Time Frame: 6 months ]
    To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment


Secondary Outcome Measures:
  • Efficacy and Safety of Oral Versus Intravenous Ibuprofen [ Time Frame: Results will be identified in 6 months ]
    Evaluation of renal tolerance and complications


Estimated Enrollment: 70
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intravenous ibuprofen
Extremely low birth weight patients receiving iv ibuprofen
Drug: oral ibuprofen
oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals
Active Comparator: Oral ibuprofen
Extremely low birth weight patients receiving oral ibuprofen
Drug: oral ibuprofen
oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals

Detailed Description:

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weight below 1000 gram
  • Diagnosed patent ductus arteriosis by Echocardiographic examination

Exclusion Criteria:

  • Accompanied other congenital cardiac anomalies
  • Severe thrombocytopenia < 60.000
  • Severe intracranial bleeding (Grade 3-4)
  • Intestinal abnormality and necrotising enterocolitis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01261117


Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey, 06600
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Study Director: Omer Erdeve Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01261117     History of Changes
Other Study ID Numbers: STO5336205575
First Submitted: November 29, 2010
First Posted: December 16, 2010
Last Update Posted: August 9, 2011
Last Verified: November 2010

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
Patent ductus arteriosis
İbuprofen
Extremely Low Birth Weigh infant

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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