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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01536158 |
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Date of registration:
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15/02/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
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Scientific title:
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Oral Paracetamol Versus Oral Ibuprofen Treatment |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01536158 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Mehmet Yekta Oncel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Zekai Tahir Burak Women's Health Research and Education Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Birth weight below 1250 gram
- Diagnosed patent ductus arteriosus by Echocardiographic examination
Exclusion Criteria:
- Accompanied other congenital cardiac anomalies
- Urine output of less than 1 ml/kg/h during the preceding 8 h,
- Serum creatinine level >1.6 mg/dl,
- Platelet count <60,000/mm3,
- Liver failure,
- Hyperbilirubinemia requiring exchange transfusion
- Severe intracranial bleeding (Grade III - IV)
- Intestinal abnormality and necrotising enterocolitis
Age minimum:
N/A
Age maximum:
10 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Patent Ductus Arteriosus
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Intervention(s)
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Drug: Oral paracetamol
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Drug: Oral ibuprofen
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Primary Outcome(s)
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Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen
[Time Frame: Until discharge]
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Secondary Outcome(s)
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Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants
[Time Frame: corrected 36 weeks or until discharge]
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Secondary ID(s)
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ZTB150212
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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