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

checkorphan
Learn more about:
Patent ductus arteriosus
Related Clinical Trial
Clinical Profile of Neonates Having Patent Ductus Arteriosus Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen Aminoglycosides and Duct Radiation-Free Heart Catheterization Using MRI Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease The Preterm Infants’ Paracetamol Study Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD Hyperion™ International Registry Trial NIRS in PDA VLBW Infants Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance Comparison of Oral and Intravenous Ibuprofen for PDA Treatment in Premature Infants The Impact of Platelet Functions on Spontaneous Ductal Closure in Preterm Infants Lifetech CeraFlex™ Post-Market Surveillance Study Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications Nit-Occlud PDA Post-Approval Study Ibuprofen and Renal Function in Premature Infants A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation Canadian National PDA Treatment Study Long Term Results of 450 Percutaneous Closures of PDA in a Single Center Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants AMPLATZER Duct Occluder II Additional Sizes A NEW SCORING SYSTEM FOR PREDICTION OF PDA Clinical Trial to Evaluate Two Guidelines for the Administration of Ibuprofen in the Treatment of Persistent Ductus Arteriosus Eco-guided: Impact in the Intestinal Prognosis Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population. Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA) Ibuprofen vs. Continuous Indomethacin in the Treatment of PDA Addition of Acetaminophen in Standard PDA Management Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA) Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates Paracetamol Versus Ibuprofen for PDA Closure Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants Early Treatment Versus Expectative Management of PDA in Preterm Infants International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants Do Elevated BNP Levels Predict Hemodynamically Significant PDAs The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants Brain, Gut and Kidney Blood Flow During Medical Closure of PDA Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term AMPLATZER Duct Occluder II Clinical Study The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Preterm Birth Paracetamol and Patent Ductus Arteriosus (PDA) Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure Pocket Echocardiography System (PES) for Detection of PDA in Neonates Treating the Resistant Patent Ductus Arteriosus (PDA) Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus IV Acetaminophen and Patent Ductus Arteriosus Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI) Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus. Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

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