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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Versus Intravenous Ibuprofen Treatment

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Drug: oral ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous ibuprofen<br>Extremely low birth weight patients receiving iv ibuprofen | Drug: oral ibuprofen<br>* oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals<br>|
| Active Comparator: Oral ibuprofen<br>Extremely low birth weight patients receiving oral ibuprofen | Drug: oral ibuprofen<br>* oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety of Oral Versus Intravenous Ibuprofen | Evaluation of renal tolerance and complications | Results will be identified in 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant