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

Patent Ductus Arteriosus Clinical Trial

Official title:

Oral Versus Intravenous Ibuprofen Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261117
• Other study ID #: STO5336205575
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: August 8, 2011
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2010
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• oral ibuprofen
oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575	To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment	6 months	Yes
Secondary	Efficacy and Safety of Oral Versus Intravenous Ibuprofen	Evaluation of renal tolerance and complications	Results will be identified in 6 months	Yes