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

Not Applicable

Completed

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: oral ibuprofen

• Registration Number: NCT01261117
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Status Verified: 2010-11
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2011-04
• Study Completion: 2011-06
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous ibuprofen	oral ibuprofen	Extremely low birth weight patients receiving iv ibuprofen
Oral ibuprofen	oral ibuprofen	Extremely low birth weight patients receiving oral ibuprofen

Primary Outcome Measures

Name	Time	Method
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575	6 months	To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment

Secondary Outcome Measures

Name	Time	Method
Efficacy and Safety of Oral Versus Intravenous Ibuprofen	Results will be identified in 6 months	Evaluation of renal tolerance and complications

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Teaching Hospital; 🇹🇷 Ankara, Turkey