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

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Patent ductus arteriosus
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Brief Title

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

Official Title

Oral Versus Intravenous Ibuprofen Treatment

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.

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

Primary Outcome

Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575

Secondary Outcome

 Efficacy and Safety of Oral Versus Intravenous Ibuprofen

Condition

Patent Ductus Arteriosus

Intervention

oral ibuprofen

Study Arms / Comparison Groups

 intravenous ibuprofen
Description:  Extremely low birth weight patients receiving iv ibuprofen

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

70

Start Date

January 2009

Completion Date

June 2011

Primary Completion Date

April 2011

Eligibility 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

Gender

All

Ages

N/A - 7 Days

Accepts Healthy Volunteers

No

Contacts

Omer Erdeve, ,

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations

NCT ID

NCT01261117

Organization ID

STO5336205575

Study Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Study Sponsor

Omer Erdeve, Study Director, Zekai Tahir Burak Women's Health Research and Education Hospital

Verification Date

November 2010