Status:

COMPLETED

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

Lead Sponsor:

Zekai Tahir Burak Women's Health Research and Education Hospital

Conditions:

Patent Ductus Arteriosus

Eligibility:

All Genders

1-7 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • Accompanied other congenital cardiac anomalies
  • Severe thrombocytopenia \< 60.000
  • Severe intracranial bleeding (Grade 3-4)
  • Intestinal abnormality and necrotising enterocolitis

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2011

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT01261117

Start Date

January 1 2009

End Date

June 1 2011

Last Update

August 9 2011

Active Locations (1)

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1

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Turkey (Türkiye), 06600