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