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

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ClinicalTrials.gov Identifier: NCT01261117
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : August 9, 2011
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary:
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 or disease Intervention/treatment
Patent Ductus Arteriosus Drug: oral ibuprofen

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Oral Versus Intravenous Ibuprofen Treatment
Study Start Date : January 2009
Primary Completion Date : April 2011
Study Completion Date : June 2011


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. Efficacy and Safety of Oral Versus Intravenous Ibuprofen [ Time Frame: Results will be identified in 6 months ]
    Evaluation of renal tolerance and complications



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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

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

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01261117     History of Changes
Other Study ID Numbers: STO5336205575
First Posted: December 16, 2010    Key Record Dates
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