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

This study has been completed.
Sponsor:
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01261117
First received: November 29, 2010
Last updated: August 8, 2011
Last verified: November 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Oral Versus Intravenous Ibuprofen Treatment

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261117

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey, 06600
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
Study Director: Omer Erdeve Zekai Tahir Burak Maternity Teaching Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01261117     History of Changes
Other Study ID Numbers: STO5336205575
Study First Received: November 29, 2010
Last Updated: August 8, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Maternity and Teaching 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013