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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Drug: oral ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01261117

STO5336205575

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

intravenous ibuprofen

Active Comparator group

Description:

Extremely low birth weight patients receiving iv ibuprofen

Treatment:

Drug: oral ibuprofen

Oral ibuprofen

Active Comparator group

Description:

Extremely low birth weight patients receiving oral ibuprofen

Treatment:

Drug: oral ibuprofen